Clinical trial NCT04596384: Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery
Official title: Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Digestive System Carcinoma
Genitourinary System Carcinoma
Malignant Female Reproductive System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Cancer Institute (NCI)
First posted: 2020-10-22
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Daily Step Count
timeFrame: Baseline up to day 14
measure: Time to Early Withdrawal
timeFrame: Up to 4 months
measure: Qualitative Data
timeFrame: Up to 4 months
measure: Post-operative Complications
timeFrame: Up to 30 days after surgery
measure: Maximum CCI
timeFrame: Up to 30 days post-discharge
Secondary outcomes:
measure: Time to Hospital Readmission
timeFrame: Up to 90 days post-discharge
measure: Change in Sedentary Time
timeFrame: Baseline up to 4 months
measure: Change in General Symptoms
timeFrame: Baseline up to 4 months
measure: Change in Disease-specific Symptoms
timeFrame: Baseline up to 4 months
measure: Change in Sleep
timeFrame: Baseline up to 4 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References: