Trial Outcomes & Findings for Perioperative Telemonitoring to Optimize Cancer Care and Outcomes (NCT NCT04986566)
NCT ID: NCT04986566
Last Updated: 2025-12-05
Results Overview
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).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Results posted on
2025-12-05
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
55
|
59
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
Baseline characteristics by cohort
| Measure |
Arm I (Telemonitoring)
n=64 Participants
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
|
Arm II (Enhanced Usual Care)
n=65 Participants
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
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=37 Participants
|
52 years
n=37 Participants
|
53 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=37 Participants
|
24 Participants
n=37 Participants
|
56 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=37 Participants
|
41 Participants
n=37 Participants
|
73 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=37 Participants
|
20 Participants
n=37 Participants
|
33 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=37 Participants
|
45 Participants
n=37 Participants
|
96 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=37 Participants
|
11 Participants
n=37 Participants
|
28 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
9 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=37 Participants
|
41 Participants
n=37 Participants
|
72 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=37 Participants
|
9 Participants
n=37 Participants
|
20 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=37 Participants
|
65 participants
n=37 Participants
|
129 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).Population: Eight of the 129 randomized patients did not provide data for this outcome due to aborted surgery.
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).
Outcome measures
| Measure |
Arm I (Telemonitoring)
n=62 Participants
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
|
Arm II (Enhanced Usual Care)
n=59 Participants
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
|
|---|---|---|
|
Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)
|
0 score on a scale
Interval 0.0 to 8.7
|
0 score on a scale
Interval 0.0 to 8.7
|
PRIMARY outcome
Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).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.
Outcome measures
| Measure |
Arm I (Telemonitoring)
n=64 Participants
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
|
Arm II (Enhanced Usual Care)
n=65 Participants
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
|
|---|---|---|
|
Number of Participants Who Completed >= 70% of the Study
Quality of life measures
|
54 Participants
|
58 Participants
|
|
Number of Participants Who Completed >= 70% of the Study
Patient-generated health data
|
54 Participants
|
57 Participants
|
|
Number of Participants Who Completed >= 70% of the Study
Daily step counts
|
54 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).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.
Outcome measures
| Measure |
Arm I (Telemonitoring)
n=64 Participants
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
|
Arm II (Enhanced Usual Care)
n=65 Participants
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
|
|---|---|---|
|
Number of Participants Who Reported Intervention Acceptability
|
50 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
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.
Outcome measures
| Measure |
Arm I (Telemonitoring)
n=64 Participants
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
|
Arm II (Enhanced Usual Care)
n=65 Participants
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
|
|---|---|---|
|
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)
Day 14 post-discharge
|
1.48 score on a scale
Interval 1.11 to 1.8
|
2.2 score on a scale
Interval 1.9 to 2.5
|
|
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)
Day 30 post-discharge
|
1.21 score on a scale
Interval 0.9 to 1.6
|
2.05 score on a scale
Interval 1.7 to 2.4
|
|
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)
Baseline
|
1.81 score on a scale
Interval 1.5 to 2.1
|
1.73 score on a scale
Interval 1.4 to 2.0
|
|
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)
Day 2 post-discharge
|
2.63 score on a scale
Interval 2.3 to 3.0
|
2.92 score on a scale
Interval 2.6 to 3.3
|
|
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)
Day 7 post-discharge
|
1.74 score on a scale
Interval 1.4 to 2.1
|
2.27 score on a scale
Interval 1.9 to 2.6
|
SECONDARY outcome
Timeframe: Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
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.
Outcome measures
| Measure |
Arm I (Telemonitoring)
n=63 Participants
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
|
Arm II (Enhanced Usual Care)
n=65 Participants
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
|
|---|---|---|
|
Participant Reported Quality of Life as Measured by the EQ-5D-5L.
Day 2 post-discharge
|
0.57 score on a scale
Interval 0.5 to 0.6
|
0.54 score on a scale
Interval 0.5 to 0.6
|
|
Participant Reported Quality of Life as Measured by the EQ-5D-5L.
Day 7 post-discharge
|
0.69 score on a scale
Interval 0.6 to 0.7
|
0.61 score on a scale
Interval 0.6 to 0.7
|
|
Participant Reported Quality of Life as Measured by the EQ-5D-5L.
Day 14 post-discharge
|
0.72 score on a scale
Interval 0.07 to 0.8
|
0.67 score on a scale
Interval 0.6 to 0.7
|
|
Participant Reported Quality of Life as Measured by the EQ-5D-5L.
Day 30 post-discharge
|
0.8 score on a scale
Interval 0.7 to 0.9
|
0.75 score on a scale
Interval 0.7 to 0.8
|
|
Participant Reported Quality of Life as Measured by the EQ-5D-5L.
Baseline
|
0.86 score on a scale
Interval 0.8 to 0.9
|
0.85 score on a scale
Interval 0.8 to 0.9
|
SECONDARY outcome
Timeframe: Up to day 30 post-dischargePopulation: Eight of the 129 randomized patients did not provide data for this outcome due to aborted surgery.
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.
Outcome measures
| Measure |
Arm I (Telemonitoring)
n=62 Participants
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
|
Arm II (Enhanced Usual Care)
n=59 Participants
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
|
|---|---|---|
|
Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission)
|
10 Participants
|
13 Participants
|
Adverse Events
Arm I (Telemonitoring)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Enhanced Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place