Adherence to Medication Regime, Cancer
Conditions
Keywords
Oral Chemotherapy, Cancer
Brief summary
Many people treated for cancer receive oral chemotherapy medications for their illness. This means that much of their cancer care occurs at home, away from a traditional oncology care setting. The purpose of this study is to explore how a Smartphone mobile application (mobile app) can help improve the cancer treatment process in people who are prescribed oral chemotherapy medication. The investigators will explore how well the mobile app helps patients stay connected with their oncology care team, take their oral medications as prescribed, and manage their cancer-related symptoms from home. This study will be done in two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention, and 2) a randomized-controlled trial to test the intervention.
Detailed description
Background: Over the last decade, novel targeted agents have revolutionized the delivery of cancer care and improved survival rates, especially in those with metastatic disease. While oral chemotherapies possess significant advantages with respect to ease of administration, patients and caregivers receive less support for adherence and monitoring of side effects. Therefore, novel interventions are essential to help patients communicate in a more open and timely manner with their oncology clinicians to support adherence. As part of Phase 1 for this Patient-Centered Outcomes Research Institute (PCORI) grant, we conducted qualitative interviews with patients, clinicians and relevant stakeholders to inform the development of the proposed mobile app intervention. For the randomized-controlled trial, the investigators will recruit and randomly assign 180 adult patients prescribed oral chemotherapy to receive either the intervention (completed smartphone mobile app) or standard care. Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of a mobile application to help improve adherence to oral chemotherapy and symptom to patients with cancer. We will administer the intervention at three cancer centers, hypothesizing that patients with who use the mobile app will report better adherence to their oral chemotherapy and better management of symptoms than those patients who were not assigned to the intervention. Specific Aims: The primary aims of this study are 1) to implement a patient-centered mobile application to assess symptoms, side effects, and adherence to oral chemotherapy that is feasible for use in oncology patients, and 2) to evaluate the efficacy of the mobile application in improving patient-reported clinical outcomes. Study Design: We will recruit and randomly assign 180 patients from the three cancer care sites who have recently been prescribed oral chemotherapy to receive either the mobile app intervention or standard care. Participants will be stratified by study site (i.e. Massachusetts General Hospital (MGH), North Shore, MGH West, and Emerson Cancer Centers), cancer type, and line of chemotherapy. This will ensure relatively equal percentages of patients from each study site, diagnosis, and line of chemotherapy will be represented in the treatment and control groups. The mobile app intervention which will consist of completing an initial chemotherapy treatment plan with their oncology clinicians, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses each week for 12 weeks. Medication adherence, symptom severity, and quality of life will serve as primary outcomes, and we will collect measures of quality cancer care as secondary targets. We will also explore whether particular patient characteristics (i.e. cancer type, demographics) affect patient response to the mobile app intervention.
Interventions
Participants assigned to the intervention group will receive the mobile application intervention for approximately three months after enrollment. The mobile app intervention will consist of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app will also be transmitted in real-time to the participants' oncology clinicians via a HIPAA-compliant, secure email.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Participant Inclusion Criteria * Age greater than 18 years * Diagnosis of cancer with a new or existing prescription for oral chemotherapy * Receiving cancer care at either Massachusetts General Hospital Cancer Center or community affiliates (North Shore or Emerson Hospitals) * Eastern Cooperative Oncology Group (ECOG) ranging from 0 (asymptomatic) to 2 (symptomatic and in bed \>50% of the day) * Able to read and respond to questions in English * Uses smart mobile phone (either operating system (iOS) \[iPhone\] or Android device) Clinician Participant Inclusion Criteria - Clinician participants must be oncology clinicians (i.e. physicians and nurse practitioners) who maintain at least 25% clinical practice at the Massachusetts General Hospital Cancer Center or one of its community affiliates at the North Shore or Emerson Hospital. Stakeholder Participant Inclusion Criteria - Four groups of stakeholders will provide ongoing feedback about the study design, methods, and results. To be eligible as a stakeholder, the participant must be able to represent the interests and perspective of at least one of the following stakeholder groups: * Oncology Patient or Family Member * Oncology Clinician (e.g., Physician or Nurse Practitioner) * Cancer Practice Setting Administrator Health System, Community, and Society.
Exclusion criteria
Patient Participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week | Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment | The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate yes or no to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week. Participants who answered yes to any of the four items were coded as having adherence problems, while those who indicated no to all four items were coded as having no adherence problems. Therefore, the count of participants is the number of participants who reported any difficulties with adherence on any of the four items in the past week. |
| Adherence to Oral Chemotherapy Medication | Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline) | Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened. |
| Change in Symptoms and Side Effects | Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline) | M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being not present or did not interfere and 10 being as bad as you can imagine or interfered completely. The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only), with possible scores on both subscales ranging from 0-10. Higher scores indicate worse symptom severity and interference, while lower scores indicate less symptom severity and interference. |
| Change in Quality of Life | Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline) | Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, while lower scores indicate a worse quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Visits | Post-Assessment (12-14 weeks after baseline) | Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have gone to the emergency room in the past three months on a numerical scale ranging from 0 to 5 or more. Scores ranged from 0-5. A higher score represents more frequent emergency department visits, indicating higher resource utilization. |
| Hospitalizations | Post-Assessment (12-14 weeks after baseline) | Description: Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have been admitted to the hospital in the past three months on a numerical scale ranging from 0 to 5 or more. Scores ranged from 0-5. A higher score represents more frequent hospital admissions, indicating higher resource utilization. |
| Treatment Satisfaction | Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline) | Description: Functional Assessment of Chronic Illness Treatment-Treatment Satisfaction-Patient Satisfaction (FACIT-TS-PS), 21-items that assesses patient satisfaction with doctor and staff competence, communication, and confidence and trust in providers, as well as overall satisfaction of care (self-report). The FACIT-TS-PS uses a 0-3 numerical rating scale to assess satisfaction with healthcare, with 0 representing the lowest level of satisfaction and 3 representing the highest level of satisfaction. Four subscales are computed by taking the sum: explanations (4 items; range 0-12), interpersonal (3 items, range 0-9), comprehensive care (7 items; range 0-21), nurses (3 items; range 0-9), and trust (4 items; range 0-12). A higher score indicates greater satisfaction with care, while a lower score represents lower satisfaction with care. |
Countries
United States
Participant flow
Recruitment details
From 2/13/15-12/31/16, patients with diverse malignancies were recruited from the outpatient oncology clinics at Massachusetts General Hospital Cancer Center and three community affiliates (i.e., Mass General/North Shore Cancer Center, Mass General Cancer Center at Mass General West, Mass General Cancer Center at Emerson Hospital-Bethke).
Pre-assignment details
Of the 212 patients enrolled in our study, 181 were randomized. There were 28 participants who dropped out of the study after enrollment but prior to randomization, and 3 participants who were lost to follow-up after enrollment but prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Mobile Application Intervention Mobile Application Intervention: Participants assigned to the intervention group received the mobile application intervention for approximately three months after enrollment. The mobile app intervention consisted of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app were transmitted weekly to the participants' oncology clinicians via a HIPAA-compliant, secure email. | 91 |
| Standard Oncology Care Participants in the control group received standard oncology care only, and completed baseline and post-assessments. | 90 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 0 |
Baseline characteristics
| Characteristic | Mobile Application Intervention | Standard Oncology Care | Total |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 13.7 | 53.8 years STANDARD_DEVIATION 12.1 | 53.3 years STANDARD_DEVIATION 12.9 |
| Cancer Type Breast | 11 Participants | 15 Participants | 26 Participants |
| Cancer Type Gastrointestinal | 6 Participants | 2 Participants | 8 Participants |
| Cancer Type Genito-urinary | 4 Participants | 3 Participants | 7 Participants |
| Cancer Type Hematologic | 30 Participants | 30 Participants | 60 Participants |
| Cancer Type High grade Glioma | 9 Participants | 12 Participants | 21 Participants |
| Cancer Type Low grade Glioma | 1 Participants | 4 Participants | 5 Participants |
| Cancer Type Melanoma | 4 Participants | 3 Participants | 7 Participants |
| Cancer Type Non-GIST Sarcoma | 1 Participants | 1 Participants | 2 Participants |
| Cancer Type Non-small cell lung cancer | 17 Participants | 16 Participants | 33 Participants |
| Cancer Type Sarcoma | 8 Participants | 4 Participants | 12 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0 | 40 Participants | 49 Participants | 89 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1 | 47 Participants | 40 Participants | 87 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 2 | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 82 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Oral Therapy Type Chemotherapy | 26 Participants | 34 Participants | 60 Participants |
| Oral Therapy Type Targeted therapy | 65 Participants | 56 Participants | 121 Participants |
| Race/Ethnicity, Customized African American or Black | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic/Latino/a | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 84 Participants | 75 Participants | 159 Participants |
| Sex: Female, Male Female | 46 Participants | 51 Participants | 97 Participants |
| Sex: Female, Male Male | 45 Participants | 39 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 91 | 1 / 90 |
| other Total, other adverse events | 1 / 91 | 0 / 90 |
| serious Total, serious adverse events | 0 / 91 | 0 / 90 |
Outcome results
Primary
Adherence to Oral Chemotherapy Medication
Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.
Time frame: Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)
Population: Analysis population is the number of participants who had data available from the Medication Event Monitoring System (MEMS) and completed the Multidimensional Scale of Perceived Social Support (MSPSS) at both the baseline and post assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application Intervention | Adherence to Oral Chemotherapy Medication | 81.50 percentage of medication taken | Standard Deviation 2.93 |
| Standard Oncology Care | Adherence to Oral Chemotherapy Medication | 79.16 percentage of medication taken | Standard Deviation 2.78 |
Comparison: Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.5795% CI: [-10.35, 5.68]Regression, Linear
Primary
Change in Quality of Life
Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, while lower scores indicate a worse quality of life.
Time frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the FACT-General (FACT-G) and the Multidimensional Scale of Perceived Social Support (MSPSS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Application Intervention | Change in Quality of Life | FACT-Physical Well-Being | 0.81 units on the FACT-G scale | Standard Error 0.48 |
| Mobile Application Intervention | Change in Quality of Life | FACT-Emotional Well-Being | 0.04 units on the FACT-G scale | Standard Error 0.41 |
| Mobile Application Intervention | Change in Quality of Life | FACT-Social Well-Being | -0.55 units on the FACT-G scale | Standard Error 0.53 |
| Mobile Application Intervention | Change in Quality of Life | FACT-Functional Well-Being | 0.35 units on the FACT-G scale | Standard Error 0.43 |
| Mobile Application Intervention | Change in Quality of Life | FACT-General | 0.49 units on the FACT-G scale | Standard Error 1.19 |
| Standard Oncology Care | Change in Quality of Life | FACT-Functional Well-Being | -0.40 units on the FACT-G scale | Standard Error 0.41 |
| Standard Oncology Care | Change in Quality of Life | FACT-General | -1.93 units on the FACT-G scale | Standard Error 1.13 |
| Standard Oncology Care | Change in Quality of Life | FACT-Physical Well-Being | 0.11 units on the FACT-G scale | Standard Error 0.45 |
| Standard Oncology Care | Change in Quality of Life | FACT-Social Well-Being | -2.22 units on the FACT-G scale | Standard Error 0.5 |
| Standard Oncology Care | Change in Quality of Life | FACT-Emotional Well-Being | 0.53 units on the FACT-G scale | Standard Error 0.4 |
Comparison: Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.14495% CI: [-5.66, 0.83]Regression, Linear
Comparison: Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.p-value: 0.29495% CI: [-2, 0.61]Regression, Linear
Comparison: Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.02595% CI: [-3.12, -0.21]Regression, Linear
Comparison: Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.39295% CI: [-0.64, 1.63]Regression, Linear
Comparison: Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.21695% CI: [-1.94, 0.44]Regression, Linear
Primary
Change in Symptoms and Side Effects
M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being not present or did not interfere and 10 being as bad as you can imagine or interfered completely. The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only), with possible scores on both subscales ranging from 0-10. Higher scores indicate worse symptom severity and interference, while lower scores indicate less symptom severity and interference.
Time frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Population: Participants who completed both baseline and post measures of the MDASI and the Multidimensional Scale of Perceived Social Support (MSPSS). Due to a clerical error, the MDASI was not administered to 31 pts at baseline. One pt skipped the symptom interference scale, causing a discrepancy in the number of pts completing each subscale on the MDASI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Application Intervention | Change in Symptoms and Side Effects | Change in Symptom Severity | -0.03 units on MDASI scale | Standard Error 0.15 |
| Mobile Application Intervention | Change in Symptoms and Side Effects | Change in Symptom Interference | -0.12 units on MDASI scale | Standard Error 0.23 |
| Standard Oncology Care | Change in Symptoms and Side Effects | Change in Symptom Severity | 0.08 units on MDASI scale | Standard Error 0.15 |
| Standard Oncology Care | Change in Symptoms and Side Effects | Change in Symptom Interference | -0.11 units on MDASI scale | Standard Error 0.23 |
Comparison: Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.60395% CI: [-0.31, 0.53]Regression, Linear
Comparison: Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.p-value: 0.98295% CI: [-0.64, 0.65]Regression, Linear
Primary
Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week
The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate yes or no to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week. Participants who answered yes to any of the four items were coded as having adherence problems, while those who indicated no to all four items were coded as having no adherence problems. Therefore, the count of participants is the number of participants who reported any difficulties with adherence on any of the four items in the past week.
Time frame: Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment
Population: Analysis population is the number of participants who completed the post-assessment measure of the MMAS-4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Application Intervention | Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week | 11 Participants |
| Standard Oncology Care | Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week | 20 Participants |
Comparison: Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.18695% CI: [0.23, 1.33]Regression, Logistic
Secondary
Emergency Department Visits
Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have gone to the emergency room in the past three months on a numerical scale ranging from 0 to 5 or more. Scores ranged from 0-5. A higher score represents more frequent emergency department visits, indicating higher resource utilization.
Time frame: Post-Assessment (12-14 weeks after baseline)
Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the Resource Utilization Questionnaire (RUQ) and the Multidimensional Scale of Perceived Social Support (MSPSS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application Intervention | Emergency Department Visits | 0.16 Scores on a scale | Standard Deviation 0.04 |
| Standard Oncology Care | Emergency Department Visits | 0.14 Scores on a scale | Standard Deviation 0.04 |
Comparison: Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.68295% CI: [-0.15, 0.1]Regression, Linear
Secondary
Hospitalizations
Description: Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have been admitted to the hospital in the past three months on a numerical scale ranging from 0 to 5 or more. Scores ranged from 0-5. A higher score represents more frequent hospital admissions, indicating higher resource utilization.
Time frame: Post-Assessment (12-14 weeks after baseline)
Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the Resource Utilization Questionnaire (RUQ) and the Multidimensional Scale of Perceived Social Support (MSPSS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application Intervention | Hospitalizations | 0.20 Scores on a scale | Standard Deviation 0.07 |
| Standard Oncology Care | Hospitalizations | 0.15 Scores on a scale | Standard Deviation 0.07 |
Comparison: Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessmentp-value: 0.6495% CI: [-0.24, 0.15]Regression, Linear
Secondary
Treatment Satisfaction
Description: Functional Assessment of Chronic Illness Treatment-Treatment Satisfaction-Patient Satisfaction (FACIT-TS-PS), 21-items that assesses patient satisfaction with doctor and staff competence, communication, and confidence and trust in providers, as well as overall satisfaction of care (self-report). The FACIT-TS-PS uses a 0-3 numerical rating scale to assess satisfaction with healthcare, with 0 representing the lowest level of satisfaction and 3 representing the highest level of satisfaction. Four subscales are computed by taking the sum: explanations (4 items; range 0-12), interpersonal (3 items, range 0-9), comprehensive care (7 items; range 0-21), nurses (3 items; range 0-9), and trust (4 items; range 0-12). A higher score indicates greater satisfaction with care, while a lower score represents lower satisfaction with care.
Time frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the FACIT-TS-PS and the Multidimensional Scale of Perceived Social Support (MSPSS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Application Intervention | Treatment Satisfaction | FACIT-Interpersonal Treatment | 0.07 units on FACIT-TS-PS scale | Standard Deviation 0.13 |
| Mobile Application Intervention | Treatment Satisfaction | FACIT-Nursing Care | -0.45 units on FACIT-TS-PS scale | Standard Deviation 0.2 |
| Mobile Application Intervention | Treatment Satisfaction | FACIT-Comprehensive Care | 0.08 units on FACIT-TS-PS scale | Standard Deviation 0.52 |
| Mobile Application Intervention | Treatment Satisfaction | FACIT-Trust in Clinicians | -0.24 units on FACIT-TS-PS scale | Standard Deviation 0.13 |
| Mobile Application Intervention | Treatment Satisfaction | FACIT-Clinician Explanations | 0.04 units on FACIT-TS-PS scale | Standard Deviation 0.2 |
| Standard Oncology Care | Treatment Satisfaction | FACIT-Trust in Clinicians | -0.24 units on FACIT-TS-PS scale | Standard Deviation 0.12 |
| Standard Oncology Care | Treatment Satisfaction | FACIT-Clinician Explanations | -0.34 units on FACIT-TS-PS scale | Standard Deviation 0.19 |
| Standard Oncology Care | Treatment Satisfaction | FACIT-Interpersonal Treatment | -0.29 units on FACIT-TS-PS scale | Standard Deviation 0.13 |
| Standard Oncology Care | Treatment Satisfaction | FACIT-Comprehensive Care | -0.89 units on FACIT-TS-PS scale | Standard Deviation 0.49 |
| Standard Oncology Care | Treatment Satisfaction | FACIT-Nursing Care | -0.26 units on FACIT-TS-PS scale | Standard Deviation 0.19 |
Comparison: Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.1795% CI: [-0.93, 0.17]Regression, Linear
Comparison: Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.05795% CI: [-0.72, 0.01]Regression, Linear
Comparison: Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.17895% CI: [-2.39, 0.45]Regression, Linear
Comparison: Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.48195% CI: [-0.35, 0.75]Regression, Linear
Comparison: Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.p-value: 0.9795% CI: [-0.34, 0.35]Regression, Linear