Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery

NCT04596384 | Active Not Recruiting Results DMC

• 3 other identifiers: 20370NCI-2020-07889P30CA033572
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 3

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.

Conditions

Digestive System Carcinoma; Genitourinary System Carcinoma; Malignant Female Reproductive System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Time to Hospital Readmission

  Up to 90 days post-discharge

• Change in Sedentary Time

  Baseline up to 4 months

• Change in General Symptoms

  Baseline up to 4 months

• Change in Disease-specific Symptoms

  Baseline up to 4 months

• Change in Sleep

  Baseline up to 4 months

Study Arms (2)

Group I (telemonitoring program, actigraph, TapCloud)

EXPERIMENTAL

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; Other: Medical Device Usage and Evaluation; Procedure: Nutritional Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: TapCloud

Group II (surgeon-only perioperative care program)

ACTIVE COMPARATOR

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Participate in a surgeon-only perioperative care program

Also known as: standard of care, standard therapy

Group II (surgeon-only perioperative care program)

Functional Assessment PROCEDURE

Complete a functional assessment

Group I (telemonitoring program, actigraph, TapCloud)

Medical Device Usage and Evaluation OTHER

Wear an actigraph

Group I (telemonitoring program, actigraph, TapCloud)

Nutritional Assessment PROCEDURE

Complete a nutritional assessment

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

Group I (telemonitoring program, actigraph, TapCloud)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (telemonitoring program, actigraph, TapCloud); Group II (surgeon-only perioperative care program)

Questionnaire Administration OTHER

Ancillary studies

Group I (telemonitoring program, actigraph, TapCloud); Group II (surgeon-only perioperative care program)

TapCloud OTHER

Use TapCloud app

Group I (telemonitoring program, actigraph, TapCloud)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

City of Hope Antelope Valley

Lancaster, California, 93534, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Related Publications (1)

• Sun V, Xiao Y, Li S, Palmer J, Tribby CP, Crane TE, Melstrom L, Dellinger T, Yuh B, Raz D, Cota-Robles E, Cota-Robles L, Nolde M, Ferrell B, Fong Y. Comparative effectiveness of remote perioperative telemonitoring in cancer surgery: a randomized trial. NPJ Digit Med. 2025 Aug 28;8(1):555. doi: 10.1038/s41746-025-01961-z.

  PMID: 40877442 DERIVED

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Nutrition Assessment

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Virginia Sun, Professor
• Organization: City of Hope

VSun@coh.org

+16269888652

Study Officials

• Virginia Sun

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: February 16, 2021
• Primary Completion: September 30, 2023
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 19, 2025
• Results First Posted: March 15, 2024

Record last verified: 2025-07

Locations

US (3)