An interventional study of Best Practice and Health Education in Malignant Digestive System Neoplasm, sponsored by City of Hope Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 134 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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Exclusion Criteria:
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.
Other: Best Practice · Behavioral: Health Education · Other: Medical Device Usage and Evaluation · Other: Quality-of-Life Assessment
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.
Other: Best Practice · Behavioral: Health Education · Other: Medical Device Usage and Evaluation · Other: Quality-of-Life Assessment
Use standard reporting procedures
Also known as: standard of care
Use Aetonixx app
Wear Vivofit 4
Complete questionnaires
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).
Time frame: 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.
Time frame: 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.
Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to day 30 post-discharge
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.
| Milestone | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Started | 64 | 65 |
| Completed | 55 | 59 |
| Not completed | 9 | 6 |
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).
| score on a scale | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Patient Postoperative Complications Using the Comprehensive Complications Index (CCI) | 0 (0 to 8.7) | 0 (0 to 8.7) |
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.
| Participants | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Daily step counts | 54 | 56 |
| Quality of life measures | 54 | 58 |
| Patient-generated health data | 54 | 57 |
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.
| Participants | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Number of Participants Who Reported Intervention Acceptability | 50 | 52 |
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.
| score on a scale | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Baseline | 1.81 (1.5 to 2.1) | 1.73 (1.4 to 2.0) |
| Day 2 post-discharge | 2.63 (2.3 to 3.0) | 2.92 (2.6 to 3.3) |
| Day 7 post-discharge | 1.74 (1.4 to 2.1) | 2.27 (1.9 to 2.6) |
| Day 14 post-discharge | 1.48 (1.11 to 1.8) | 2.2 (1.9 to 2.5) |
| Day 30 post-discharge | 1.21 (0.9 to 1.6) | 2.05 (1.7 to 2.4) |
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.
| score on a scale | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Baseline | 0.86 (0.8 to 0.9) | 0.85 (0.8 to 0.9) |
| Day 2 post-discharge | 0.57 (0.5 to 0.6) | 0.54 (0.5 to 0.6) |
| Day 7 post-discharge | 0.69 (0.6 to 0.7) | 0.61 (0.6 to 0.7) |
| Day 14 post-discharge | 0.72 (.07 to 0.8) | 0.67 (0.6 to 0.7) |
| Day 30 post-discharge | 0.8 (0.7 to 0.9) | 0.75 (0.7 to 0.8) |
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.
| Participants | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) |
|---|---|---|
| Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission) | 10 | 13 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Telemonitoring) | 0/64 (0%) | — | — |
| Arm II (Enhanced Usual Care) | 1/65 (1.5%) | — | — |
| Age, Continuous(years) | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) | Total |
|---|---|---|---|
| Median | 53 (47 to 64) | 52 (48 to 65) | 53 (47 to 65) |
| Sex: Female, Male(Participants) | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) | Total |
|---|---|---|---|
| Female | 32 | 24 | 56 |
| Male | 32 | 41 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 20 | 33 |
| Not Hispanic or Latino | 51 | 45 | 96 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 17 | 11 | 28 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 4 | 9 |
| White | 31 | 41 | 72 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 9 | 20 |
| Region of Enrollment(participants) | Arm I (Telemonitoring) | Arm II (Enhanced Usual Care) | Total |
|---|---|---|---|
| United States | 64 | 65 | 129 |
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