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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
Be older than 18 years old
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 belowSelect...
I am scheduled for major surgery for cancer in my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
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 moreSecondary outcome measures
Change in Disease-specific Symptoms
Change in General Symptoms
Change in Sedentary Time
+2 moreTrial 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
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,966 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,218 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
554 Previous Clinical Trials
29,944,954 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for major surgery for cancer in my abdomen.I can read and understand either English or Spanish.My condition is at any stage of the disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (surgeon-only perioperative care program)
- Group 2: Group I (telemonitoring program, actigraph, TapCloud)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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