Home-Based Telemonitoring Program for Functional Recovery and Symptoms in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
This phase III trial compares a home-based telemonitoring program that collects symptom and daily step information to surgeon only care in improving recovery and stopping complications within 30 days after surgery in patients with gastrointestinal, genitourinary, or gynecologic cancer who are scheduled to undergo abdominal surgery. Patients may experience a decrease in functional capacity and experience symptoms like pain and fatigue after surgery, and this may change their ability to walk and function. Home-based telemonitoring of patient symptoms and their ability to walk and function after surgery may help doctors and nurses find and treat problems early, which may improve the patient's recovery and lower the number of complications after surgery.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on clinically significant changes in functional recovery (accelerometer daily step count) and related secondary patient-centered outcomes (sleep, sedentary time, symptom severity, symptom interference with daily activities). II. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on postoperative complications (Comprehensive Complications Index - CCI) and related secondary surgical outcomes (hospital readmission). III. Compare early withdrawal (dropout or loss of accelerometer device) between the comparators. IV. Explore perioperative telemonitoring care-related experiences (acceptability, technology usability, uptake/integration) among patients, families, and surgeons through qualitative focus groups and exit interviews. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (REMOTE PERIOPERATIVE TELEMONITORING CARE GROUP): Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud application (app) on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to a registered nurse (RN) when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing. GROUP II (SURGEON ONLY PERIOPERATIVE CARE GROUP): Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing. After completion of study, patients are followed up for 3-4 months.

Official Title
-----------------
Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms

Conditions
-----------------
Digestive System Carcinoma, Genitourinary System Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Other: Best Practice
* Procedure: Functional Assessment
* Other: Medical Device Usage and Evaluation
* Procedure: Nutritional Assessment
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: TapCloud


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients scheduled to undergo major abdominal surgery for gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) malignancies Ability to read and understand English or Spanish Patients across all stages of disease 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (telemonitoring program, actigraph, TapCloud)<br>Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud app on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to an RN when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing. | Procedure: Functional Assessment<br>* Complete a functional assessment<br>Other: Medical Device Usage and Evaluation<br>* Wear an actigraph<br>Procedure: Nutritional Assessment<br>* Complete a nutritional assessment<br>* Other names: nutritional counseling;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: TapCloud<br>* Use TapCloud app<br>|
| Active Comparator: Group II (surgeon-only perioperative care program)<br>Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing. | Other: Best Practice<br>* Participate in a surgeon-only perioperative care program<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily step count | Will calculate percent change from preoperative baseline in daily step count during the first 2 weeks post-discharge from hospital. Will use generalized linear mixed modeling (with treatment and covariates as fixed factors, patient identification as random factor). | Baseline up to day 14 | 
| Time to early withdrawal | Analyzed using proportional hazards regression. | Up to 4 months | 
| Qualitative data | Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach. | Up to 4 months | 
| Post-operative complications | Assessed using the Comprehensive Complications Index (CCI) which summarizes the entire patient postoperative experience with respect to complications (on a scale from 0 to 100), and is based on the established Clavien-Dindo classification. For CCI score: Higher = worse | Up to 30 days after surgery | 
| Maximum CCI | Maximum CCI will be categorized as above versus below 15, and logistic regression will be used to evaluate the effect of study intervention. | Up to 30 days post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hospital readmission | Will be subjected to survival analysis. | Up to 90 days post-discharge | 
| Change in sedentary time | Assessed using the Actigraph GT9X Link. Data capture will focus on the following: 1) number of steps taken per day and 2) sedentary time. Recommended activity counts per minute (cpm) cutpoints will be used to categorize sedentary time (< 100 cpm) from light-intensity physical activity (100-1951 cpm) and moderate/vigorous intensity physical activity (>=1952 cpm). | Baseline up to 4 months | 
| Change in general symptoms | Assessed using the MD Anderson Symptom Inventory. | Baseline up to 4 months | 
| Change in disease-specific symptoms | Assessed using the MD Anderson Symptom Library Items. | Baseline up to 4 months | 
| Change in sleep | Assessed using the MD Anderson Symptom Inventory. | Baseline up to 4 months |