Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03335 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20717 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| R21NR019866 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.
PRIMARY OBJECTIVE:
I. To conduct a pilot randomized trial of a remote, perioperative telemonitoring intervention to improve patient-centered outcomes, surgical outcomes, and healthcare resource use in English and Spanish-speaking patients scheduled to undergo major abdominal gastrointestinal (GI) cancer surgery.
Ia. Assess the feasibility, retention, and acceptability of the remote perioperative telemonitoring intervention as measured by the percentage of patients who a) agree to participate; b) complete >= 70% of the telemonitoring; and c) report satisfaction with the intervention through structured exit interviews.
Ib. Determine the preliminary efficacy of the remote perioperative telemonitoring intervention on surgical outcomes, healthcare utilization, patient-reported outcomes (PROs), and functional recovery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TELEMONITORING): Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx application (app) up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures.
ARM II (ENHANCED USUAL CARE): Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (telemonitoring) | Experimental | Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures. |
|
| Arm II (enhanced usual care) | Active Comparator | Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Use standard reporting procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Postoperative Complications Using the Comprehensive Complications Index (CCI) | Postoperative complications occurring within 30 days post-discharge after cancer surgery were measured using the Comprehensive Complications index (CCI), a validated tool that aggregates the Clavien grades of postoperative complications on a continuous scale ranging from 0 (no complication) to 100 (death). | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). |
| Number of Participants Who Completed >= 70% of the Study | Study completion was assessed based on the percentage of patients who completed at least 70% of the following during the study period: (a) daily step counts, (b) quality of life measures, and (c) patient-generated health data. These measures were assessed from baseline through 30 days post-discharge after cancer surgery. | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). |
| Number of Participants Who Reported Intervention Acceptability | Acceptability of telemonitoring was assessed using a patient satisfaction tool administered within 30 days post-discharge after cancer surgery. The tool evaluated ease of use, time burden of participation, and access to technology. | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine." Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in symptom severity between both arms over time. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laleh Melstrom | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
A total of 188 eligible patients were approached for study participation. Of these, 54 declined for various reasons: not tech-savvy (n = 2), no time/too busy (n = 13), not interested in clinical research (n = 5), feeling overwhelmed (n = 10), other reasons (n = 6), and two or more of the aforementioned reasons (n = 18). Ultimately, 134 patients consented to participate. After excluding 5 patients due to late ineligibility, 129 patients were randomized.
A total of 188 eligible patients were approached for study participation. Of these, 54 declined for various reasons: not tech-savvy (n = 2), no time/too busy (n = 13), not interested in clinical research (n = 5), feeling overwhelmed (n = 10), other reasons (n = 6), and two or more of the aforementioned reasons (n = 18). Ultimately, 134 patients consented to participate. After excluding 5 patients due to late ineligibility, 129 patients were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Telemonitoring) | Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires |
| FG001 | Arm II (Enhanced Usual Care) | Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Telemonitoring) | Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Patient Postoperative Complications Using the Comprehensive Complications Index (CCI) | Postoperative complications occurring within 30 days post-discharge after cancer surgery were measured using the Comprehensive Complications index (CCI), a validated tool that aggregates the Clavien grades of postoperative complications on a continuous scale ranging from 0 (no complication) to 100 (death). | Eight of the 129 randomized patients did not provide data for this outcome due to aborted surgery. | Posted | Median | Inter-Quartile Range | score on a scale | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). |
|
This is an intervention trial lasting three months post-treatment, with no blood draws, procedures, or other invasive assessments. Since this is not a drug trial, patients were not monitored for specific adverse events. However, one patient died prior to study participation. Each participant was monitored for mortality during the three-month post-discharge period.
Since this is not a drug trial, adverse events were not recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Telemonitoring) | Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Laleh Melstrom | City of Hope Medical Center | 626-359-8111 | lmelstrom@coh.org |
Not provided
| 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 | May 24, 2023 | Aug 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2023 | Mar 13, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Health Education | Behavioral | Use Aetonixx app |
|
| Medical Device Usage and Evaluation | Other | Wear Vivofit 4 |
|
| Quality-of-Life Assessment | Other | Complete questionnaires |
|
| Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge. |
| Participant Reported Quality of Life as Measured by the EQ-5D-5L. | The EQ-5D-5L descriptive system of 5 health dimensions includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. Index scores range from -0.59 to 1 where 1 is the best possible health state. Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in QoL scores between both arms over time. | Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge. |
| Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission) | Differences in the number of patients readmitted to the hospital for an overnight stay within 30 days post-discharge were compared between the two study arms using the Chi-square test or Fisher's exact test. | Up to day 30 post-discharge |
| BG001 | Arm II (Enhanced Usual Care) | Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm II (Enhanced Usual Care) | Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires |
|
|
| Primary | Number of Participants Who Completed >= 70% of the Study | Study completion was assessed based on the percentage of patients who completed at least 70% of the following during the study period: (a) daily step counts, (b) quality of life measures, and (c) patient-generated health data. These measures were assessed from baseline through 30 days post-discharge after cancer surgery. | Posted | Count of Participants | Participants | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). |
|
|
|
| Primary | Number of Participants Who Reported Intervention Acceptability | Acceptability of telemonitoring was assessed using a patient satisfaction tool administered within 30 days post-discharge after cancer surgery. The tool evaluated ease of use, time burden of participation, and access to technology. | Posted | Count of Participants | Participants | Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18). |
|
|
|
| Secondary | Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI) | The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine." Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in symptom severity between both arms over time. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge. |
|
|
|
| Secondary | Participant Reported Quality of Life as Measured by the EQ-5D-5L. | The EQ-5D-5L descriptive system of 5 health dimensions includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. Index scores range from -0.59 to 1 where 1 is the best possible health state. Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in QoL scores between both arms over time. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge. |
|
|
|
| Secondary | Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission) | Differences in the number of patients readmitted to the hospital for an overnight stay within 30 days post-discharge were compared between the two study arms using the Chi-square test or Fisher's exact test. | Eight of the 129 randomized patients did not provide data for this outcome due to aborted surgery. | Posted | Count of Participants | Participants | Up to day 30 post-discharge |
|
|
|
| 0 |
| 64 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm II (Enhanced Usual Care) | Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems. Best Practice: Use standard reporting procedures Health Education: Use Aetonixx app Medical Device Usage and Evaluation: Wear Vivofit 4 Quality-of-Life Assessment: Complete questionnaires | 1 | 65 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D005767 |
| Gastrointestinal Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| Patient-generated health data |
|
| Day 2 post-discharge |
|
|
| Day 7 post-discharge |
|
|
| Day 14 post-discharge |
|
|
| Day 30 post-discharge |
|
|
| Day 2 post-discharge |
|
|
| Day 7 post-discharge |
|
|
| Day 14 post-discharge |
|
|
| Day 30 post-discharge |
|
|