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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04596384
Other study ID # 20370
Secondary ID NCI-2020-0788920
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 16, 2021
Est. completion date November 30, 2024

Study information

Verified date March 2024
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States City of Hope Comprehensive Cancer Center Duarte California
United States City of Hope Antelope Valley Lancaster California
United States City of Hope South Pasadena South Pasadena California

Sponsors (3)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Time to Early Withdrawal Analyzed using proportional hazards regression. Up to 4 months
Primary Qualitative Data Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach. Up to 4 months
Primary 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
Primary 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 Time to Hospital Readmission Will be subjected to survival analysis. Up to 90 days post-discharge
Secondary Change in Sedentary Time Assessed using the Actigraph GT9X Link. Data capture will focus on the following: 1) number of steps taken per day and 2) sedentary time. Recommended activity counts per minute (cpm) cutpoints will be used to categorize sedentary time (< 100 cpm) from light-intensity physical activity (100-1951 cpm) and moderate/vigorous intensity physical activity (>=1952 cpm). Baseline up to 4 months
Secondary Change in General Symptoms Assessed using the MD Anderson Symptom Inventory. Baseline up to 4 months
Secondary Change in Disease-specific Symptoms Assessed using the MD Anderson Symptom Library Items. Baseline up to 4 months
Secondary Change in Sleep Assessed using the MD Anderson Symptom Inventory. Baseline up to 4 months
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