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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07889 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20370 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (telemonitoring program, actigraph, TapCloud) | Experimental | 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. |
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| Group II (surgeon-only perioperative care program) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Participate in a surgeon-only perioperative care program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to Early Withdrawal | Analyzed using proportional hazards regression. | Up to 4 months |
| Qualitative Data | Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach. | 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 | 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. | Up to 30 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hospital Readmission | Will be subjected to survival analysis. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| City of Hope Antelope Valley |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40877442 | Derived | Sun V, Xiao Y, Li S, Palmer J, Tribby CP, Crane TE, Melstrom L, Dellinger T, Yuh B, Raz D, Cota-Robles E, Cota-Robles L, Nolde M, Ferrell B, Fong Y. Comparative effectiveness of remote perioperative telemonitoring in cancer surgery: a randomized trial. NPJ Digit Med. 2025 Aug 28;8(1):555. doi: 10.1038/s41746-025-01961-z. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2022 |
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| Functional Assessment | Procedure | Complete a functional assessment |
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| Medical Device Usage and Evaluation | Other | Wear an actigraph |
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| Nutritional Assessment | Procedure | Complete a nutritional assessment |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| TapCloud | Other | Use TapCloud app |
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| Baseline up to 4 months |
| Change in General Symptoms | Assessed using the MD Anderson Symptom Inventory. | Baseline up to 4 months |
| Change in Disease-specific Symptoms | Assessed using the MD Anderson Symptom Library Items. | Baseline up to 4 months |
| Change in Sleep | Assessed using the MD Anderson Symptom Inventory. | Baseline up to 4 months |
| Lancaster |
| California |
| 93534 |
| United States |
| City of Hope South Pasadena | South Pasadena | California | 91030 | United States |
| FG001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Not Posted | Sep 2026 | Baseline up to day 14 | Participants | ||||||||||||||||
| Primary | Time to Early Withdrawal | Analyzed using proportional hazards regression. | Not Posted | Sep 2026 | Up to 4 months | Participants | ||||||||||||||||
| Primary | Qualitative Data | Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach. | Not Posted | Up to 4 months | Participants | |||||||||||||||||
| 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 | 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. | Posted | Median | Full Range | units on a scale | Up to 30 days after surgery |
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| 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. | Posted | Count of Participants | Participants | Up to 30 days post-discharge |
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| Secondary | Time to Hospital Readmission | Will be subjected to survival analysis. | Not Posted | Up to 90 days post-discharge | Participants | |||||||||||||||||
| 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). | Not Posted | Baseline up to 4 months | Participants | |||||||||||||||||
| Secondary | Change in General Symptoms | Assessed using the MD Anderson Symptom Inventory. | Not Posted | Baseline up to 4 months | Participants | |||||||||||||||||
| Secondary | Change in Disease-specific Symptoms | Assessed using the MD Anderson Symptom Library Items. | Not Posted | Baseline up to 4 months | Participants | |||||||||||||||||
| Secondary | Change in Sleep | Assessed using the MD Anderson Symptom Inventory. | Not Posted | Baseline up to 4 months | Participants |
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.
Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. Please see above regarding adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 189 | 0 | 0 | 0 | 0 |
| EG001 | 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 | 4 | 193 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Virginia Sun, Professor | City of Hope | +16269888652 | VSun@coh.org |
| Dec 22, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | 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 |
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