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

Malignant Solid Neoplasm Clinical Trial

Official title:

Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms

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
• 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
• 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:

PRIMARY OBJECTIVES:

I. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on clinically significant changes in functional recovery (accelerometer daily step count) and related secondary patient-centered outcomes (sleep, sedentary time, symptom severity, symptom interference with daily activities).

II. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on postoperative complications (Comprehensive Complications Index - CCI) and related secondary surgical outcomes (hospital readmission).

III. Compare early withdrawal (dropout or loss of accelerometer device) between the comparators.

IV. Explore perioperative telemonitoring care-related experiences (acceptability, technology usability, uptake/integration) among patients, families, and surgeons through qualitative focus groups and exit interviews.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (REMOTE PERIOPERATIVE TELEMONITORING CARE GROUP): 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 application (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 a registered nurse (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 (SURGEON ONLY PERIOPERATIVE CARE GROUP): 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.

After completion of study, patients are followed up for 3-4 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 398
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carcinoma
• Digestive System Carcinoma
• Genital Neoplasms, Female
• Genitourinary System Carcinoma
• Malignant Female Reproductive System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

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
• Questionnaire Administration
Ancillary studies
• TapCloud
Use TapCloud app

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