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Telemonitoring Program for Abdominal Cancers

N/A
Waitlist Available
Led By Virginia Sun
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights

Study Summary

This trial compares a home-based telemonitoring program to surgeon only care in improving recovery and stopping complications after surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
There may not be traditional 'side effects' as this isn't testing a drug but rather a monitoring program. However, participants might experience discomfort or privacy concerns related to constant health tracking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for major surgery for cancer in my abdomen.
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I can read and understand either English or Spanish.
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My condition is at any stage of the disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Daily Step Count
Maximum CCI
Post-operative Complications
+2 more
Secondary outcome measures
Change in Disease-specific Symptoms
Change in General Symptoms
Change in Sedentary Time
+2 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Functional Assessment
2013
N/A
~20
Nutritional Assessment
2013
N/A
~10

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,248 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,054 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,996,189 Total Patients Enrolled

Media Library

TapCloud Clinical Trial Eligibility Overview. Trial Name: NCT04596384 — N/A
Cancer Research Study Groups: Group I (telemonitoring program, actigraph, TapCloud), Group II (surgeon-only perioperative care program)
Cancer Clinical Trial 2023: TapCloud Highlights & Side Effects. Trial Name: NCT04596384 — N/A
TapCloud 2023 Treatment Timeline for Medical Study. Trial Name: NCT04596384 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants in this trial at present?

"Affirmative. According to clinicaltrials.gov, this medical study is presently actively recruiting individuals for participation. It was initially posted on February 16th 2021 and was most recently updated on July 6th 2022 - with a total of 332 participants needed from 3 distinct sites."

Answered by AI

What would be the anticipated results of this examination?

"This clinical trial's primary aim is to determine the maximum Clinical Condition Index (CCI) over a period of 30 days following surgery. Secondary objectives include monitoring changes in overall symptoms through MD Anderson Symptom Inventory, sedentary time via Actigraph GT9X Link and disease-specific indicators with MD Anderson Symptom Library Items. The data collected will focus on two metrics: number of steps taken daily and sedentary time which can be categorised into low (<100 cpm), moderate/vigorous (>1952 cpm) levels using recommended activity counts per minute cutpoints."

Answered by AI
~97 spots leftby Mar 2025