Gynecologic Cancer
Conditions
Keywords
Gynecologic cancer
Brief summary
This research study is evaluating a new smartphone application named the Helping Our Patients Excel (HOPE) app with a Fitbit device. The SMART Study is a sub-study of the HOPE Trial. Both studies evaluate an almost identical intervention using a Fitbit device and smartphone app(s) with the goal of improving quality-of-life for women with gynecologic cancers.
Detailed description
The HOPE Trial: The first goal of this study is to adapt and refine an existing smartphone app, paired with a wearable accelerometer, to assess patients' symptoms in a population of patients with gynecologic cancers receiving palliative chemotherapy. An existing app will be customized to collect patient-reported toxicities using the Patient-Reported Outcome (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and offer patients feedback about how to manage their symptoms. Patient symptoms will be risk-stratified. Patients with low-risk toxicities (grades 1 & 2) will receive tailored educational information, while patients with serious toxicities (grades 3 & 4) will receive alerts to call their clinician. In the first phase of the study, we will conduct an initial assessment of the app with a diverse group of 10 patients to refine the app and test two different wearable accelerometers (i.e. Fitbit Zip and Fitbit Charge 2) before pilot testing. The second goal of this study is to conduct a pilot randomized controlled trial (RCT) of the smartphone app and/or wearable accelerometer (i.e. Fitbit Zip or Fitbit Charge 2) to assess the feasibility, acceptability, and preliminary efficacy of our intervention. During the second phase of the study, we will conduct a 4-arm pilot RCT in 100 patients with gynecologic cancers receiving palliative chemotherapy to establish preliminary effect sizes. Participants will be randomized to: 1) Fitbit+active app, 2) Fitbit+passive app, 3) Active app, or 4) Passive app. We expect that the results of this pilot RCT, which is supported by the National Cancer Institute, National Palliative Care Research Center, and the Dana-Farber Cancer Institute Department of Medical Oncology, will provide a low-cost, scalable system to assess patients' symptoms, address low-risk toxicities, and alert clinicians when patients have toxicities that require intervention with the goal of reducing patient suffering and the use of high-intensity, hospital-based health care. The SMART Study: The overall goals of this study are to test the combination of two smartphone research platforms and a wearable accelerometer for use in NCI Community Oncology Research Program (NCORP) sites to improve cancer patients' quality of life and symptom management. The SMART Study (Symptom Management and Reporting Toxicities) has a single-arm research design and aims to assess the feasibility, acceptability, and perceived efficacy of a wearable accelerometer and two smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic cancers.
Interventions
DEVICEFitbit Zip
Fitbit Zip
OTHERHOPE App
HOPE App
OTHERStandard of Care
Standard of Care
DEVICEFitbit Charge 2
Fitbit Charge 2
OTHERSMART Study Intervention
SMART study app + Beiwe study app + Fitbit
Sponsors
National Institute of Nursing Research (NINR)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥18 years of age * Who plan to receive chemotherapy at DFCI to treat recurrent, incurable gynecologic cancers (ovarian, uterine, cervical) that have recurred despite ≥1 prior treatments. * Own a smart-phone (Android or iOS) * Capable of downloading and running the study app without assistance * Can read and provide informed consent in English * Do not have cognitive or visual impairments that would preclude use of the app.
Exclusion criteria
* Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment. * Patients with severe cognitively impairments * Who appear too weak * Emotionally distraught * Agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded. * Patients who are unable to provide informed consent in English will be excluded because the smartphone app intervention is only available in English at this time. * Children and young adults up to age 18 will be excluded because the diagnosis of metastatic gynecologic cancers in this age group is rare and the proposed instruments are not designed for people of those ages. * Patients with a life expectancy of ≤6 months, as determined by their oncology providers, will be excluded since they cannot participate in all of the required data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) | 30 days | This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) Participating in this study placed a substantial burden on me. (2) I wish I had not agreed to participate in this study. and (3) I would recommend the application to a friend going through treatment. |
| Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10) | 30 days | This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study. |
| Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study | 90 days | SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer. |
| Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study | 90 days | SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Acceptability defined as responses to three questions: (1) Participating in this study placed a substantial burden on me.; (2) I wish I had not agreed to participate in this study.; and (3) I would recommend the application to a friend going through treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Anxiety as Assessed by GAD-7 (HOPE RCT) | Baseline, 30 days, 90 days, 180 days (Phase II) | Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. \[The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.} |
| Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Baseline, 30 days, 90 days, 180 days (Phase II) | Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation. |
| Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
| Depression as Assessed by PHQ-9 (HOPE RCT) | Baseline, 30 days, 90 days, 180 days (Phase II) | Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.} |
| Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Baseline, 30 days, 90 days, 180 days (Phase II) | Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.} |
| Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline, 30 days, 90 days, 180 days (Phase II) | Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comparing Steps Collected by Accelerometer (HOPE) * 10 patients will be enrolled in stage 1 to refine the HOPE App intervention
* All participants will receive :
* HOPE App
* The Fitbit Zip
* The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2
Fitbit Zip: Fitbit Zip
HOPE App: HOPE App
Fitbit Charge 2: Fitbit Charge 2 | 10 |
| Refined Smartphone App and Accelerometer (HOPE) * Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
Participants will be asked to wear the Fitbit
-The Hope App will measure daily steps The app will also collect passive data from the smartphone
HOPE App: HOPE App | 23 |
| Wearable Accelerometer (HOPE) * Participants will be asked to wear the Fitbit
* The Hope App will measure daily steps
* The app will also collect passive data from the smartphone
HOPE App: HOPE App
Fitbit Charge 2: Fitbit Charge 2 | 21 |
| Refined Smartphone App (HOPE) * Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
* The app will also collect passive data from the smartphone
HOPE App: HOPE App | 22 |
| Usual Care (HOPE) Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
* Usual care
* The app will also collect passive data from the smartphone
HOPE App: HOPE App
Standard of Care: Standard of Care | 22 |
| SMART Study Arm * Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.
* The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).
* The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).
* The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.
SMART Study Intervention: SMART study app + Beiwe study app + Fitbit | 4 |
| Total | 102 |
Baseline characteristics
| Characteristic | Total | SMART Study Arm | Usual Care (HOPE) | Refined Smartphone App (HOPE) | Wearable Accelerometer (HOPE) | Refined Smartphone App and Accelerometer (HOPE) | Comparing Steps Collected by Accelerometer (HOPE) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.75 years STANDARD_DEVIATION 10.07 | 65.50 years STANDARD_DEVIATION 8.85 | 59.64 years STANDARD_DEVIATION 9.31 | 62.09 years STANDARD_DEVIATION 8.19 | 63.76 years STANDARD_DEVIATION 8.43 | 61.52 years STANDARD_DEVIATION 13.36 | 59.9 years STANDARD_DEVIATION 11.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 3 Participants | 21 Participants | 22 Participants | 21 Participants | 22 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Last grade level completed 8th grade or less | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Last grade level completed 9 - 11th grade | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Last grade level completed Advanced degree | 38 Participants | 0 Participants | 7 Participants | 10 Participants | 5 Participants | 10 Participants | 6 Participants |
| Last grade level completed Associate degree or some college | 25 Participants | 1 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 3 Participants |
| Last grade level completed Bachelor's degree | 27 Participants | 2 Participants | 8 Participants | 3 Participants | 9 Participants | 5 Participants | 0 Participants |
| Last grade level completed Don't know | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Last grade level completed High school graduate or GED | 9 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Last grade level completed Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Last grade level completed Refused | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Last grade level completed Vocational or Technical training | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Marital Status Divorced/Separated | 15 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 5 Participants | 0 Participants |
| Marital Status Married | 64 Participants | 2 Participants | 14 Participants | 14 Participants | 12 Participants | 14 Participants | 8 Participants |
| Marital Status Missing | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Never Married | 14 Participants | 0 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 1 Participants |
| Marital Status Widowed | 7 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race Asian | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race Black or African American | 7 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race Don't know | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race Other | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race Refuse to answer | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race White | 83 Participants | 4 Participants | 17 Participants | 21 Participants | 15 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Female | 102 Participants | 4 Participants | 22 Participants | 22 Participants | 21 Participants | 23 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 23 | 0 / 21 | 0 / 22 | 2 / 22 | 0 / 4 |
| other Total, other adverse events | 10 / 10 | 22 / 23 | 19 / 21 | 21 / 22 | 18 / 22 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 23 | 0 / 21 | 0 / 22 | 0 / 22 | 0 / 4 |
Outcome results
Primary
Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Acceptability defined as responses to three questions: (1) Participating in this study placed a substantial burden on me.; (2) I wish I had not agreed to participate in this study.; and (3) I would recommend the application to a friend going through treatment.
Time frame: 90 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study | Acceptability - (3) I would recommend the application to a friend going through treatment. | 4 Participants |
| HOPE Pre-pilot | Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study | Acceptability - (1) Participating in this study placed a substantial burden on me. | 0 Participants |
| HOPE Pre-pilot | Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study | Acceptability - (2) I wish I had not agreed to participate in this study. | 0 Participants |
Primary
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) Participating in this study placed a substantial burden on me. (2) I wish I had not agreed to participate in this study. and (3) I would recommend the application to a friend going through treatment.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) | Feasibility - (1) greater than or equal to 60% enrollment rate among eligible patients approached | 10 Participants |
| HOPE Pre-pilot | Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) | Feasibility - (2) greater than or equal to 70% adherence to daily smartphone surveys | 7 Participants |
| HOPE Pre-pilot | Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) | Feasibility - (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week | 9 Participants |
| HOPE Pre-pilot | Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) | Acceptability - (1) Participating in this study placed a substantial burden on me. | 1 Participants |
| HOPE Pre-pilot | Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) | Acceptability - (2) I wish I had not agreed to participate in this study. | 1 Participants |
Primary
Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study
SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HOPE Pre-pilot | Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study | 4 Participants |
Primary
Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)
This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.
Time frame: 30 days
Population: This outcome was limited to the HOPE pilot, consisting of 10 patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HOPE Pre-pilot | Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10) | Preferred FitBit Charge | 9 participants |
| HOPE Pre-pilot | Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10) | Preferred FitBit Zip | 1 participants |
Secondary
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 12 Participants |
| HOPE Pre-pilot | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| HOPE Pre-pilot | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 6 Participants |
| HOPE Pre-pilot | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 3 Participants |
| Arm 2: Fitbit+Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 5 Participants |
| Arm 2: Fitbit+Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 2: Fitbit+Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 8 Participants |
| Arm 3: Active App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 3 Participants |
| Arm 3: Active App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 3: Active App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 6 Participants |
| Arm 3: Active App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 10 Participants |
| Arm 4: Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 8 Participants |
| Arm 4: Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 6 Participants |
| Arm 4: Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 16 Participants |
| Arm 4: Passive App | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 7 Participants |
Secondary
Anxiety as Assessed by GAD-7 (HOPE RCT)
Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. \[The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HOPE Pre-pilot | Anxiety as Assessed by GAD-7 (HOPE RCT) | Baseline | 3.43 GAD-7 Total score | Standard Deviation 2.98 |
| HOPE Pre-pilot | Anxiety as Assessed by GAD-7 (HOPE RCT) | 30 days post-baseline | 3.17 GAD-7 Total score | Standard Deviation 3.24 |
| HOPE Pre-pilot | Anxiety as Assessed by GAD-7 (HOPE RCT) | 90 days post-baseline | 3.50 GAD-7 Total score | Standard Deviation 3.55 |
| HOPE Pre-pilot | Anxiety as Assessed by GAD-7 (HOPE RCT) | 180 days post-baseline | 0.78 GAD-7 Total score | Standard Deviation 0.97 |
| Arm 2: Fitbit+Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 30 days post-baseline | 5.09 GAD-7 Total score | Standard Deviation 4.46 |
| Arm 2: Fitbit+Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 90 days post-baseline | 3.38 GAD-7 Total score | Standard Deviation 4.03 |
| Arm 2: Fitbit+Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 180 days post-baseline | 3.78 GAD-7 Total score | Standard Deviation 4.09 |
| Arm 2: Fitbit+Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | Baseline | 3.74 GAD-7 Total score | Standard Deviation 4.19 |
| Arm 3: Active App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 90 days post-baseline | 2.92 GAD-7 Total score | Standard Deviation 2.47 |
| Arm 3: Active App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 30 days post-baseline | 2.64 GAD-7 Total score | Standard Deviation 2.54 |
| Arm 3: Active App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 180 days post-baseline | 3.00 GAD-7 Total score | Standard Deviation 2.26 |
| Arm 3: Active App | Anxiety as Assessed by GAD-7 (HOPE RCT) | Baseline | 5.45 GAD-7 Total score | Standard Deviation 4.82 |
| Arm 4: Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 180 days post-baseline | 3.22 GAD-7 Total score | Standard Deviation 2.82 |
| Arm 4: Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 30 days post-baseline | 4.00 GAD-7 Total score | Standard Deviation 2.24 |
| Arm 4: Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | Baseline | 4.10 GAD-7 Total score | Standard Deviation 3.43 |
| Arm 4: Passive App | Anxiety as Assessed by GAD-7 (HOPE RCT) | 90 days post-baseline | 3.07 GAD-7 Total score | Standard Deviation 2.13 |
Secondary
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| HOPE Pre-pilot | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 4 Participants |
| HOPE Pre-pilot | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 4 Participants |
| HOPE Pre-pilot | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 3 Participants |
| Arm 2: Fitbit+Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 2: Fitbit+Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 3: Active App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 3 Participants |
| Arm 3: Active App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 3 Participants |
| Arm 3: Active App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 3 Participants |
| Arm 3: Active App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 4: Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 4: Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| Arm 4: Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 4: Passive App | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 3 Participants |
Secondary
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 10 Participants |
| HOPE Pre-pilot | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| HOPE Pre-pilot | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 2 Participants |
| HOPE Pre-pilot | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 2: Fitbit+Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 6 Participants |
| Arm 2: Fitbit+Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 6 Participants |
| Arm 2: Fitbit+Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 6 Participants |
| Arm 3: Active App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 5 Participants |
| Arm 3: Active App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| Arm 3: Active App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 8 Participants |
| Arm 3: Active App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 10 Participants |
| Arm 4: Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 7 Participants |
| Arm 4: Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 8 Participants |
| Arm 4: Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 11 Participants |
| Arm 4: Passive App | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 8 Participants |
Secondary
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation.
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants who had both physician- and patient-reported ECOG Performance Status (PS) assessed at baseline and/or follow-up timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HOPE Pre-pilot | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Baseline | 0.70 Weighted Kappa (no unit) |
| HOPE Pre-pilot | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 30 days post-baseline | 0.24 Weighted Kappa (no unit) |
| HOPE Pre-pilot | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 90 days post-baseline | 0.20 Weighted Kappa (no unit) |
| HOPE Pre-pilot | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 180 days post-baseline | -0.08 Weighted Kappa (no unit) |
| Arm 2: Fitbit+Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 180 days post-baseline | 0.71 Weighted Kappa (no unit) |
| Arm 2: Fitbit+Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 90 days post-baseline | 0.31 Weighted Kappa (no unit) |
| Arm 2: Fitbit+Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 30 days post-baseline | 0.59 Weighted Kappa (no unit) |
| Arm 2: Fitbit+Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Baseline | 0.48 Weighted Kappa (no unit) |
| Arm 3: Active App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 90 days post-baseline | -0.15 Weighted Kappa (no unit) |
| Arm 3: Active App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 180 days post-baseline | 0.24 Weighted Kappa (no unit) |
| Arm 3: Active App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 30 days post-baseline | 0.61 Weighted Kappa (no unit) |
| Arm 3: Active App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Baseline | 0.35 Weighted Kappa (no unit) |
| Arm 4: Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 180 days post-baseline | 0.25 Weighted Kappa (no unit) |
| Arm 4: Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Baseline | 0.39 Weighted Kappa (no unit) |
| Arm 4: Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 30 days post-baseline | 0.34 Weighted Kappa (no unit) |
| Arm 4: Passive App | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | 90 days post-baseline | 0.17 Weighted Kappa (no unit) |
Secondary
Depression as Assessed by PHQ-9 (HOPE RCT)
Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HOPE Pre-pilot | Depression as Assessed by PHQ-9 (HOPE RCT) | Baseline | 4.43 PHQ-9 total score | Standard Deviation 3.73 |
| HOPE Pre-pilot | Depression as Assessed by PHQ-9 (HOPE RCT) | 30 days post-baseline | 3.20 PHQ-9 total score | Standard Deviation 4.18 |
| HOPE Pre-pilot | Depression as Assessed by PHQ-9 (HOPE RCT) | 90 days post-baseline | 5.90 PHQ-9 total score | Standard Deviation 4.95 |
| HOPE Pre-pilot | Depression as Assessed by PHQ-9 (HOPE RCT) | 180 days post-baseline | 1.22 PHQ-9 total score | Standard Deviation 1.39 |
| Arm 2: Fitbit+Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | 30 days post-baseline | 4.58 PHQ-9 total score | Standard Deviation 4.46 |
| Arm 2: Fitbit+Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | 90 days post-baseline | 4.58 PHQ-9 total score | Standard Deviation 5.04 |
| Arm 2: Fitbit+Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | 180 days post-baseline | 3.56 PHQ-9 total score | Standard Deviation 4 |
| Arm 2: Fitbit+Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | Baseline | 3.70 PHQ-9 total score | Standard Deviation 3.48 |
| Arm 3: Active App | Depression as Assessed by PHQ-9 (HOPE RCT) | 90 days post-baseline | 3.46 PHQ-9 total score | Standard Deviation 3.26 |
| Arm 3: Active App | Depression as Assessed by PHQ-9 (HOPE RCT) | 30 days post-baseline | 3.27 PHQ-9 total score | Standard Deviation 2.9 |
| Arm 3: Active App | Depression as Assessed by PHQ-9 (HOPE RCT) | 180 days post-baseline | 3.42 PHQ-9 total score | Standard Deviation 2.43 |
| Arm 3: Active App | Depression as Assessed by PHQ-9 (HOPE RCT) | Baseline | 4.95 PHQ-9 total score | Standard Deviation 3.61 |
| Arm 4: Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | 180 days post-baseline | 5.09 PHQ-9 total score | Standard Deviation 2.98 |
| Arm 4: Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | 30 days post-baseline | 4.80 PHQ-9 total score | Standard Deviation 3.38 |
| Arm 4: Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | Baseline | 5.59 PHQ-9 total score | Standard Deviation 4.62 |
| Arm 4: Passive App | Depression as Assessed by PHQ-9 (HOPE RCT) | 90 days post-baseline | 3.87 PHQ-9 total score | Standard Deviation 1.96 |
Secondary
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 10 Participants |
| HOPE Pre-pilot | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| HOPE Pre-pilot | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 5 Participants |
| HOPE Pre-pilot | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 3 Participants |
| Arm 2: Fitbit+Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 5 Participants |
| Arm 2: Fitbit+Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 8 Participants |
| Arm 3: Active App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 4 Participants |
| Arm 3: Active App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 4 Participants |
| Arm 3: Active App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 2 Participants |
| Arm 3: Active App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 4: Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 4: Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| Arm 4: Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 11 Participants |
| Arm 4: Passive App | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 9 Participants |
Secondary
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 6 Participants |
| HOPE Pre-pilot | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| HOPE Pre-pilot | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 4 Participants |
| HOPE Pre-pilot | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 5 Participants |
| Arm 3: Active App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 2 Participants |
| Arm 3: Active App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 3: Active App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 3: Active App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 3 Participants |
| Arm 4: Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 4: Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 4: Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 4: Passive App | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 1 Participants |
Secondary
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| HOPE Pre-pilot | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 3 Participants |
| HOPE Pre-pilot | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 5 Participants |
| HOPE Pre-pilot | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 4 Participants |
| Arm 2: Fitbit+Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 3: Active App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 5 Participants |
| Arm 3: Active App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 4 Participants |
| Arm 3: Active App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 3: Active App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 12 Participants |
| Arm 4: Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 5 Participants |
| Arm 4: Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 8 Participants |
| Arm 4: Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 15 Participants |
| Arm 4: Passive App | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 6 Participants |
Secondary
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 12 Participants |
| HOPE Pre-pilot | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 7 Participants |
| HOPE Pre-pilot | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 7 Participants |
| HOPE Pre-pilot | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 2 Participants |
| Arm 2: Fitbit+Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 4 Participants |
| Arm 2: Fitbit+Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 3: Active App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 6 Participants |
| Arm 3: Active App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 5 Participants |
| Arm 3: Active App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 5 Participants |
| Arm 3: Active App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 11 Participants |
| Arm 4: Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 8 Participants |
| Arm 4: Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 7 Participants |
| Arm 4: Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 12 Participants |
| Arm 4: Passive App | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 11 Participants |
Secondary
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 10 Participants |
| HOPE Pre-pilot | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 8 Participants |
| HOPE Pre-pilot | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 6 Participants |
| HOPE Pre-pilot | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 5 Participants |
| Arm 2: Fitbit+Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 10 Participants |
| Arm 2: Fitbit+Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 7 Participants |
| Arm 2: Fitbit+Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 7 Participants |
| Arm 2: Fitbit+Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 14 Participants |
| Arm 3: Active App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 7 Participants |
| Arm 3: Active App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 4 Participants |
| Arm 3: Active App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 4 Participants |
| Arm 3: Active App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 11 Participants |
| Arm 4: Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 5 Participants |
| Arm 4: Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 11 Participants |
| Arm 4: Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 15 Participants |
| Arm 4: Passive App | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 11 Participants |
Secondary
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HOPE Pre-pilot | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 180 days post-baseline | 161.4 Total score | Standard Deviation 15.6 |
| HOPE Pre-pilot | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 30 days post-baseline | 150.7 Total score | Standard Deviation 22 |
| HOPE Pre-pilot | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 90 days post-baseline | 132.3 Total score | Standard Deviation 27.2 |
| HOPE Pre-pilot | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Baseline | 142.1 Total score | Standard Deviation 24.3 |
| Arm 2: Fitbit+Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 180 days post-baseline | 155.2 Total score | Standard Deviation 22.8 |
| Arm 2: Fitbit+Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 90 days post-baseline | 143.8 Total score | Standard Deviation 34.3 |
| Arm 2: Fitbit+Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 30 days post-baseline | 145.7 Total score | Standard Deviation 26.4 |
| Arm 2: Fitbit+Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Baseline | 147.0 Total score | Standard Deviation 23.2 |
| Arm 3: Active App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 90 days post-baseline | 150.9 Total score | Standard Deviation 20.1 |
| Arm 3: Active App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 180 days post-baseline | 144.1 Total score | Standard Deviation 17.7 |
| Arm 3: Active App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 30 days post-baseline | 147.4 Total score | Standard Deviation 19.6 |
| Arm 3: Active App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Baseline | 139.7 Total score | Standard Deviation 22.4 |
| Arm 4: Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 180 days post-baseline | 140.4 Total score | Standard Deviation 23.6 |
| Arm 4: Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Baseline | 139.4 Total score | Standard Deviation 21.1 |
| Arm 4: Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 30 days post-baseline | 145.6 Total score | Standard Deviation 18.7 |
| Arm 4: Passive App | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | 90 days post-baseline | 141.0 Total score | Standard Deviation 18.4 |
Secondary
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 5 Participants |
| HOPE Pre-pilot | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 3 Participants |
| HOPE Pre-pilot | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 4 Participants |
| HOPE Pre-pilot | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 4 Participants |
| Arm 2: Fitbit+Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 3 Participants |
| Arm 3: Active App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 2 Participants |
| Arm 3: Active App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 1 Participants |
| Arm 3: Active App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 3 Participants |
| Arm 3: Active App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 7 Participants |
| Arm 4: Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 2 Participants |
| Arm 4: Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 4: Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 3 Participants |
| Arm 4: Passive App | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 2 Participants |
Secondary
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Population: Participants with available data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HOPE Pre-pilot | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 2 Participants |
| HOPE Pre-pilot | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| HOPE Pre-pilot | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 3 Participants |
| HOPE Pre-pilot | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 0 Participants |
| Arm 2: Fitbit+Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 1 Participants |
| Arm 2: Fitbit+Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 1 Participants |
| Arm 3: Active App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 1 Participants |
| Arm 3: Active App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 2 Participants |
| Arm 3: Active App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 3 Participants |
| Arm 3: Active App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 4 Participants |
| Arm 4: Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 180 days post-baseline | 3 Participants |
| Arm 4: Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 30 days post-baseline | 1 Participants |
| Arm 4: Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Baseline | 5 Participants |
| Arm 4: Passive App | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | 90 days post-baseline | 1 Participants |