Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery
NCT04596384 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398
Last updated 2025-08-19
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.
Conditions
- Digestive System Carcinoma
- Genitourinary System Carcinoma
- Malignant Female Reproductive System Neoplasm
- Malignant Solid Neoplasm
Interventions
- OTHER
-
Best Practice
Participate in a surgeon-only perioperative care program
- PROCEDURE
-
Functional Assessment
Complete a functional assessment
- OTHER
-
Medical Device Usage and Evaluation
Wear an actigraph
- PROCEDURE
-
Nutritional Assessment
Complete a nutritional assessment
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
TapCloud
Use TapCloud app
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Virginia Sun · City of Hope Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-16
- Primary Completion
- 2023-09-30
- Completion
- 2026-11-30
Countries
- United States
Study Locations
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