An interventional study of Best Practice and Functional Assessment in Digestive System Carcinoma, Genitourinary System Carcinoma and Malignant Female Reproductive System Neoplasm, sponsored by City of Hope Medical Center. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Functional Assessment · Other: Medical Device Usage and Evaluation · Procedure: Nutritional Assessment · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Other: TapCloud
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.
Other: Best Practice · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Participate in a surgeon-only perioperative care program
Also known as: standard of care, standard therapy
Complete a functional assessment
Wear an actigraph
Complete a nutritional assessment
Also known as: Dietary Assessment, dietary counseling, nutritional counseling
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Use TapCloud app
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).
Time frame: Baseline up to day 14
Time to Early Withdrawal
Analyzed using proportional hazards regression.
Time frame: Up to 4 months
Qualitative Data
Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.
Time frame: Up to 4 months
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
Time frame: Up to 30 days after surgery
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.
Time frame: Up to 30 days post-discharge
Time to Hospital Readmission
Will be subjected to survival analysis.
Time frame: Up to 90 days post-discharge
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).
Time frame: Baseline up to 4 months
Change in General Symptoms
Assessed using the MD Anderson Symptom Inventory.
Time frame: Baseline up to 4 months
Change in Disease-specific Symptoms
Assessed using the MD Anderson Symptom Library Items.
Time frame: Baseline up to 4 months
Change in Sleep
Assessed using the MD Anderson Symptom Inventory.
Time frame: Baseline up to 4 months
398 participants were enrolled to the study, however 16 participants did not want to participate after signing consent and are considered attrition which is the reason why data analysis was done for 382 participants instead of the total consented/enrolled.
| Milestone | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) |
|---|---|---|
| Started | 189 | 193 |
| Completed | 164 | 145 |
| Not completed | 25 | 48 |
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).
Results for this outcome have not been posted.
Analyzed using proportional hazards regression.
Results for this outcome have not been posted.
Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.
Results for this outcome have not been posted.
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
| units on a scale | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) |
|---|---|---|
| Post-operative Complications | 0 (0 to 42.4) | 0 (0 to 100) |
Maximum CCI will be categorized as above versus below 15, and logistic regression will be used to evaluate the effect of study intervention.
| Participants | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) |
|---|---|---|
| High (maximum CCI >= 15) | 14 | 20 |
| Low (maximum CCI < 15) | 167 | 155 |
| Missing due to attrition or no surgery scheduled | 8 | 18 |
Will be subjected to survival analysis.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
Assessed using the MD Anderson Symptom Inventory.
Results for this outcome have not been posted.
Assessed using the MD Anderson Symptom Library Items.
Results for this outcome have not been posted.
Assessed using the MD Anderson Symptom Inventory.
Results for this outcome have not been posted.
Collected over Since this is not a drug trial, there was no specific timepoint that was monitored for an adverse event to be recorded. It's an intervention trial that lasts 90 days post-treatment with no blood draws, procedures, etc. Patients were not assessed for specific adverse events however, 4 patients died during the study due to their ongoing cancer diagnosis, not due to study participation. The time frame where each participant was monitored/assessed for death was during the 90 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I (Telemonitoring Program, Actigraph, TapCloud) | 0/189 (0%) | — | — |
| Group II (Surgeon-only Perioperative Care Program) | 4/193 (2.1%) | — | — |
| Age, Continuous(year) | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) | Total |
|---|---|---|---|
| Mean | 60.31 ± 11.72 | 60.90 ± 11.15 | 60.61 ± 11.43 |
| Sex: Female, Male(Participants) | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) | Total |
|---|---|---|---|
| Female | 88 | 95 | 183 |
| Male | 101 | 98 | 199 |
| Ethnicity (NIH/OMB)(Participants) | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) | Total |
|---|---|---|---|
| Hispanic or Latino | 67 | 63 | 130 |
| Not Hispanic or Latino | 117 | 128 | 245 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Race (NIH/OMB)(Participants) | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 14 | 16 | 30 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Black or African American | 8 | 7 | 15 |
| White | 131 | 148 | 279 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 35 | 17 | 52 |
| Region of Enrollment(participants) | Group I (Telemonitoring Program, Actigraph, TapCloud) | Group II (Surgeon-only Perioperative Care Program) | Total |
|---|---|---|---|
| United States | 189 | 193 | 382 |
Documents are hosted by the registry — open the source record to download them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
City of Hope Medical Center