Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery
NCT ID: NCT04596384
Last Updated: 2025-08-19
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
398 participants
INTERVENTIONAL
2021-02-16
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Interventions
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Best Practice
Participate in a surgeon-only perioperative care program
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Virginia Sun
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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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, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2020-07889
Identifier Type: REGISTRY
Identifier Source: secondary_id
20370
Identifier Type: OTHER
Identifier Source: secondary_id
20370
Identifier Type: -
Identifier Source: org_study_id
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