Trial Outcomes & Findings for Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery (NCT NCT04596384)

Results Overview

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).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

398 participants

Primary outcome timeframe

Baseline up to day 14

Results posted on

2025-08-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Group I (Telemonitoring Program, Actigraph, TapCloud) 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. Functional Assessment: Complete a functional assessment Medical Device Usage and Evaluation: Wear an actigraph Nutritional Assessment: Complete a nutritional assessment Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies TapCloud: Use TapCloud app	Group II (Surgeon-only Perioperative Care Program) 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. Best Practice: Participate in a surgeon-only perioperative care program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Study STARTED	189	193
Overall Study COMPLETED	164	145
Overall Study NOT COMPLETED	25	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group I (Telemonitoring Program, Actigraph, TapCloud) n=189 Participants 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. Functional Assessment: Complete a functional assessment Medical Device Usage and Evaluation: Wear an actigraph Nutritional Assessment: Complete a nutritional assessment Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies TapCloud: Use TapCloud app	Group II (Surgeon-only Perioperative Care Program) n=193 Participants 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. Best Practice: Participate in a surgeon-only perioperative care program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Total n=382 Participants Total of all reporting groups
Age, Continuous	60.31 year STANDARD_DEVIATION 11.72 • n=93 Participants	60.90 year STANDARD_DEVIATION 11.15 • n=4 Participants	60.61 year STANDARD_DEVIATION 11.43 • n=27 Participants
Sex: Female, Male Female	88 Participants n=93 Participants	95 Participants n=4 Participants	183 Participants n=27 Participants
Sex: Female, Male Male	101 Participants n=93 Participants	98 Participants n=4 Participants	199 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=93 Participants	63 Participants n=4 Participants	130 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=93 Participants	128 Participants n=4 Participants	245 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) White	131 Participants n=93 Participants	148 Participants n=4 Participants	279 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	35 Participants n=93 Participants	17 Participants n=4 Participants	52 Participants n=27 Participants
Region of Enrollment United States	189 participants n=93 Participants	193 participants n=4 Participants	382 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline up to day 14

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 4 months

Analyzed using proportional hazards regression.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 4 months

Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 30 days after surgery

Population: 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. These number are accurate for analysis based on the data collection.

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

Outcome measures

Outcome measures
Measure	Group I (Telemonitoring Program, Actigraph, TapCloud) n=189 Participants 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. Functional Assessment: Complete a functional assessment Medical Device Usage and Evaluation: Wear an actigraph Nutritional Assessment: Complete a nutritional assessment Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies TapCloud: Use TapCloud app	Group II (Surgeon-only Perioperative Care Program) n=193 Participants 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. Best Practice: Participate in a surgeon-only perioperative care program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Post-operative Complications	0 units on a scale Interval 0.0 to 42.4	0 units on a scale Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: Up to 30 days post-discharge

Maximum CCI will be categorized as above versus below 15, and logistic regression will be used to evaluate the effect of study intervention.

Outcome measures

Outcome measures
Measure	Group I (Telemonitoring Program, Actigraph, TapCloud) n=189 Participants 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. Functional Assessment: Complete a functional assessment Medical Device Usage and Evaluation: Wear an actigraph Nutritional Assessment: Complete a nutritional assessment Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies TapCloud: Use TapCloud app	Group II (Surgeon-only Perioperative Care Program) n=193 Participants 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. Best Practice: Participate in a surgeon-only perioperative care program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Maximum CCI High (maximum CCI >= 15)	14 Participants	20 Participants
Maximum CCI Low (maximum CCI < 15)	167 Participants	155 Participants
Maximum CCI Missing due to attrition or no surgery scheduled	8 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to 90 days post-discharge

Will be subjected to survival analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 4 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 4 months

Assessed using the MD Anderson Symptom Inventory.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 4 months

Assessed using the MD Anderson Symptom Library Items.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 4 months

Assessed using the MD Anderson Symptom Inventory.

Outcome measures

Outcome data not reported

Adverse Events

Group I (Telemonitoring Program, Actigraph, TapCloud)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II (Surgeon-only Perioperative Care Program)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Virginia Sun, Professor

City of Hope

Phone: +16269888652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place