Digestive System CarcinomaNCT04596384
Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery
A study testing Best Practice, Functional Assessment and Medical Device Usage and Evaluation in people with Digestive System Carcinoma and Genitourinary System Carcinoma, run by City of Hope Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digestive System Carcinoma, Genitourinary System Carcinoma, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Best Practice, Functional Assessment and Medical Device Usage and Evaluation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2021to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
City of Hope Antelope Valley
Lancaster, California, 93534
City of Hope South Pasadena
South Pasadena, California, 91030
About this study
Official title: Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Digestive System Carcinoma, Genitourinary System Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Best Practice, Functional Assessment, Medical Device Usage and Evaluation, Nutritional Assessment, Quality-of-Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Participate in a surgeon-only perioperative care program
Functional AssessmentProcedure or surgery
Complete a functional assessment
Medical Device Usage and EvaluationOther
Wear an actigraph
Nutritional AssessmentProcedure or surgery
Also called Dietary Assessment, dietary counseling, nutritional counseling
Complete a nutritional assessment
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
TapCloudOther
Use TapCloud app
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Functional Assessment; Other: Medical Device Usage and Evaluation; Procedure: Nutritional Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: TapCloud |
| 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. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline up to day 14
Time to Early Withdrawal
Analyzed using proportional hazards regression.
Measured: Up to 4 months
Qualitative Data
Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.
Measured: 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
Measured: 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.
Measured: Up to 30 days post-discharge
Secondary outcomes (5)
Time to Hospital Readmission
Will be subjected to survival analysis.
Measured: 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).
Measured: Baseline up to 4 months
Change in General Symptoms
Assessed using the MD Anderson Symptom Inventory.
Measured: Baseline up to 4 months
Change in Disease-specific Symptoms
Assessed using the MD Anderson Symptom Library Items.
Measured: Baseline up to 4 months
Change in Sleep
Assessed using the MD Anderson Symptom Inventory.
Measured: Baseline up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Feb 2021
- Primary completion30 Sep 2023
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digestive System CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Virginia Sun, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596384
- Sponsor's protocol ID
- 20370
- Other IDs
- NCI-2020-07889, 20370, P30CA033572
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2020
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40877442
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms
- ClinicalTrials.gov ID
- NCT04596384
- Acronym / sponsor ID
- 20370
- Conditions
- Digestive System Carcinoma, Genitourinary System Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 398 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Cancer Institute (NCI)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (telemonitoring program, actigraph, TapCloud) | Experimental | Procedure: Functional Assessment, Other: Medical Device Usage and Evaluation, Procedure: Nutritional Assessment, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: TapCloudBefore 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. |
| Group II (surgeon-only perioperative care program) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyParticipate in a surgeon-only perioperative care program | Other | Group II (surgeon-only perioperative care program) |
| Functional AssessmentComplete a functional assessment | Procedure or surgery | Group I (telemonitoring program, actigraph, TapCloud) |
| Medical Device Usage and EvaluationWear an actigraph | Other | Group I (telemonitoring program, actigraph, TapCloud) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingComplete a nutritional assessment | Procedure or surgery | Group I (telemonitoring program, actigraph, TapCloud) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (telemonitoring program, actigraph, TapCloud), Group II (surgeon-only perioperative care program) |
| Questionnaire AdministrationAncillary studies | Other | Group I (telemonitoring program, actigraph, TapCloud), Group II (surgeon-only perioperative care program) |
| TapCloudUse TapCloud app | Other | Group I (telemonitoring program, actigraph, TapCloud) |
Primary outcome
Change in Daily Step Count
Time frame: 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).
Time to Early Withdrawal
Time frame: Up to 4 months
Analyzed using proportional hazards regression.
Qualitative Data
Time frame: Up to 4 months
Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.
Post-operative Complications
Time frame: Up to 30 days after surgery
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
Maximum CCI
Time frame: 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.
5 secondary outcomes
Time to Hospital Readmission
Time frame: Up to 90 days post-discharge
Change in Sedentary Time
Time frame: Baseline up to 4 months
Change in General Symptoms
Time frame: Baseline up to 4 months
Change in Disease-specific Symptoms
Time frame: Baseline up to 4 months
Change in Sleep
Time frame: Baseline up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40877442Sun 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Sun principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Functional Assessment and Medical Device Usage and Evaluation in people with Digestive System Carcinoma and Genitourinary System Carcinoma, run by City of Hope Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Step Count (time frame: Baseline up to day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.