Telemonitoring Program for Abdominal Cancers

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byVirginia Sun

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Virginia Sun

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for English or Spanish-speaking cancer patients of any stage, scheduled for major abdominal surgery due to gastrointestinal, genitourinary, or gynecologic malignancies. They must be able to consent and follow safety monitoring requirements.

Inclusion Criteria

There are no restrictions related to performance status or life expectancy

I am scheduled for major surgery for cancer in my abdomen.

I can read and understand either English or Spanish.

See 2 more

Exclusion Criteria

Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Treatment Details

Interventions

Home-Based Telemonitoring Program (Behavioural Intervention)

Trial OverviewThe study compares a home-based telemonitoring program that tracks symptoms and daily steps with standard surgeon care post-surgery. The goal is to see if this improves recovery and reduces complications within 30 days after the operation.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (telemonitoring program, actigraph, TapCloud)Experimental Treatment6 Interventions

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.

Group II: Group II (surgeon-only perioperative care program)Active Control3 Interventions

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.