Malignant Digestive System Neoplasm
Conditions
Brief summary
This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.
Detailed description
PRIMARY OBJECTIVE: I. To conduct a pilot randomized trial of a remote, perioperative telemonitoring intervention to improve patient-centered outcomes, surgical outcomes, and healthcare resource use in English and Spanish-speaking patients scheduled to undergo major abdominal gastrointestinal (GI) cancer surgery. Ia. Assess the feasibility, retention, and acceptability of the remote perioperative telemonitoring intervention as measured by the percentage of patients who a) agree to participate; b) complete \>= 70% of the telemonitoring; and c) report satisfaction with the intervention through structured exit interviews. Ib. Determine the preliminary efficacy of the remote perioperative telemonitoring intervention on surgical outcomes, healthcare utilization, patient-reported outcomes (PROs), and functional recovery. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (TELEMONITORING): Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx application (app) up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures. ARM II (ENHANCED USUAL CARE): Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems.
Interventions
OTHERBest Practice
Use standard reporting procedures
BEHAVIORALHealth Education
Use Aetonixx app
OTHERMedical Device Usage and Evaluation
Wear Vivofit 4
OTHERQuality-of-Life Assessment
Complete questionnaires
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cancer patients scheduled to undergo major abdominal surgery for gastrointestinal (GI) malignancies. GI procedures include esophagectomy, gastrectomy, colectomy, abdominoperineal resection/low anterior resection, hepatectomy, pancreatectomy (distal or pancreaticoduodenectomy), and cytoreductive surgery for peritoneal carcinomatosis. We will include patients scheduled for an ostomy (colostomy or diverting ileostomy) * Age 18 years or older * Ability to read and understand English or Spanish * We are targeting patients across all stages of disease * Age criterion for this study is based on the National Institute of Health (NIH)'s age criteria, which defines an adult as individuals aged 18 years and over. There are no restrictions related to performance status or life expectancy * All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion criteria
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Postoperative Complications Using the Comprehensive Complications Index (CCI) | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). | Postoperative complications occurring within 30 days post-discharge after cancer surgery were measured using the Comprehensive Complications index (CCI), a validated tool that aggregates the Clavien grades of postoperative complications on a continuous scale ranging from 0 (no complication) to 100 (death). |
| Number of Participants Who Completed >= 70% of the Study | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). | Study completion was assessed based on the percentage of patients who completed at least 70% of the following during the study period: (a) daily step counts, (b) quality of life measures, and (c) patient-generated health data. These measures were assessed from baseline through 30 days post-discharge after cancer surgery. |
| Number of Participants Who Reported Intervention Acceptability | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). | Acceptability of telemonitoring was assessed using a patient satisfaction tool administered within 30 days post-discharge after cancer surgery. The tool evaluated ease of use, time burden of participation, and access to technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge. | The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine." Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in symptom severity between both arms over time. |
| Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge. | The EQ-5D-5L descriptive system of 5 health dimensions includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. Index scores range from -0.59 to 1 where 1 is the best possible health state. Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in QoL scores between both arms over time. |
| Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission) | Up to day 30 post-discharge | Differences in the number of patients readmitted to the hospital for an overnight stay within 30 days post-discharge were compared between the two study arms using the Chi-square test or Fisher's exact test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaleh Melstrom
City of Hope Medical Center
Participant flow
Recruitment details
A total of 188 eligible patients were approached for study participation. Of these, 54 declined for various reasons: not tech-savvy (n = 2), no time/too busy (n = 13), not interested in clinical research (n = 5), feeling overwhelmed (n = 10), other reasons (n = 6), and two or more of the aforementioned reasons (n = 18). Ultimately, 134 patients consented to participate. After excluding 5 patients due to late ineligibility, 129 patients were randomized.
Pre-assignment details
A total of 188 eligible patients were approached for study participation. Of these, 54 declined for various reasons: not tech-savvy (n = 2), no time/too busy (n = 13), not interested in clinical research (n = 5), feeling overwhelmed (n = 10), other reasons (n = 6), and two or more of the aforementioned reasons (n = 18). Ultimately, 134 patients consented to participate. After excluding 5 patients due to late ineligibility, 129 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Telemonitoring) Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures.
Best Practice: Use standard reporting procedures
Health Education: Use Aetonixx app
Medical Device Usage and Evaluation: Wear Vivofit 4
Quality-of-Life Assessment: Complete questionnaires | 64 |
| Arm II (Enhanced Usual Care) Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems.
Best Practice: Use standard reporting procedures
Health Education: Use Aetonixx app
Medical Device Usage and Evaluation: Wear Vivofit 4
Quality-of-Life Assessment: Complete questionnaires | 65 |
| Total | 129 |
Baseline characteristics
| Characteristic | Arm II (Enhanced Usual Care) | Total | Arm I (Telemonitoring) |
|---|---|---|---|
| Age, Continuous | 52 years | 53 years | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 33 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 96 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 28 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 20 Participants | 11 Participants |
| Race (NIH/OMB) White | 41 Participants | 72 Participants | 31 Participants |
| Region of Enrollment United States | 65 participants | 129 participants | 64 participants |
| Sex: Female, Male Female | 24 Participants | 56 Participants | 32 Participants |
| Sex: Female, Male Male | 41 Participants | 73 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 1 / 65 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Completed >= 70% of the Study
Study completion was assessed based on the percentage of patients who completed at least 70% of the following during the study period: (a) daily step counts, (b) quality of life measures, and (c) patient-generated health data. These measures were assessed from baseline through 30 days post-discharge after cancer surgery.
Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Telemonitoring) | Number of Participants Who Completed >= 70% of the Study | Daily step counts | 54 Participants |
| Arm I (Telemonitoring) | Number of Participants Who Completed >= 70% of the Study | Quality of life measures | 54 Participants |
| Arm I (Telemonitoring) | Number of Participants Who Completed >= 70% of the Study | Patient-generated health data | 54 Participants |
| Arm II (Enhanced Usual Care) | Number of Participants Who Completed >= 70% of the Study | Daily step counts | 56 Participants |
| Arm II (Enhanced Usual Care) | Number of Participants Who Completed >= 70% of the Study | Quality of life measures | 58 Participants |
| Arm II (Enhanced Usual Care) | Number of Participants Who Completed >= 70% of the Study | Patient-generated health data | 57 Participants |
Primary
Number of Participants Who Reported Intervention Acceptability
Acceptability of telemonitoring was assessed using a patient satisfaction tool administered within 30 days post-discharge after cancer surgery. The tool evaluated ease of use, time burden of participation, and access to technology.
Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Telemonitoring) | Number of Participants Who Reported Intervention Acceptability | 50 Participants |
| Arm II (Enhanced Usual Care) | Number of Participants Who Reported Intervention Acceptability | 52 Participants |
Primary
Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)
Postoperative complications occurring within 30 days post-discharge after cancer surgery were measured using the Comprehensive Complications index (CCI), a validated tool that aggregates the Clavien grades of postoperative complications on a continuous scale ranging from 0 (no complication) to 100 (death).
Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Population: Eight of the 129 randomized patients did not provide data for this outcome due to aborted surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Telemonitoring) | Patient Postoperative Complications Using the Comprehensive Complications Index (CCI) | 0 score on a scale |
| Arm II (Enhanced Usual Care) | Patient Postoperative Complications Using the Comprehensive Complications Index (CCI) | 0 score on a scale |
Secondary
Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission)
Differences in the number of patients readmitted to the hospital for an overnight stay within 30 days post-discharge were compared between the two study arms using the Chi-square test or Fisher's exact test.
Time frame: Up to day 30 post-discharge
Population: Eight of the 129 randomized patients did not provide data for this outcome due to aborted surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Telemonitoring) | Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission) | 10 Participants |
| Arm II (Enhanced Usual Care) | Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission) | 13 Participants |
Secondary
Participant Reported Quality of Life as Measured by the EQ-5D-5L.
The EQ-5D-5L descriptive system of 5 health dimensions includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. Index scores range from -0.59 to 1 where 1 is the best possible health state. Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in QoL scores between both arms over time.
Time frame: Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm I (Telemonitoring) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 2 post-discharge | 0.57 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 14 post-discharge | 0.72 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 7 post-discharge | 0.69 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 30 post-discharge | 0.8 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Baseline | 0.86 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 30 post-discharge | 0.75 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Baseline | 0.85 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 2 post-discharge | 0.54 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 7 post-discharge | 0.61 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | Day 14 post-discharge | 0.67 score on a scale |
Secondary
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)
The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being not present and 10 being as bad as you can imagine. Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in symptom severity between both arms over time.
Time frame: Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm I (Telemonitoring) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 2 post-discharge | 2.63 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 14 post-discharge | 1.48 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Baseline | 1.81 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 30 post-discharge | 1.21 score on a scale |
| Arm I (Telemonitoring) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 7 post-discharge | 1.74 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 30 post-discharge | 2.05 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 2 post-discharge | 2.92 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 7 post-discharge | 2.27 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Day 14 post-discharge | 2.2 score on a scale |
| Arm II (Enhanced Usual Care) | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | Baseline | 1.73 score on a scale |