Trial Outcomes & Findings for Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare® (NCT NCT05011890)
NCT ID: NCT05011890
Last Updated: 2023-10-10
Results Overview
Feasibility of self-reporting symptoms using Moovcare® is defined as the mean percentage of e-PRO surveys completed per subject using Moovcare® by 6 months or coming off study per protocol if sooner.
COMPLETED
NA
41 participants
Up to 6 months
2023-10-10
Participant Flow
Participants were recruited from 09/01/2021 through 03/14/2022 at one cancer center in North Carolina.
Forty-one participants started and completed the baseline assessment and thirty- three subjects completed the six-month assessment. Participant Flow and Baseline Characteristics are based on all participants who joined the study and completed baseline assessments.
Participant milestones
| Measure |
Single-arm Moovcare®
Participants were assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
Baseline characteristics by cohort
| Measure |
PRO Collected by Moovcare
n=41 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Age, Continuous
|
61.51 years
STANDARD_DEVIATION 11.39 • n=99 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Subjects enrolled in the study who started to use Moovcare and completed at least one survey questionnaire.
Feasibility of self-reporting symptoms using Moovcare® is defined as the mean percentage of e-PRO surveys completed per subject using Moovcare® by 6 months or coming off study per protocol if sooner.
Outcome measures
| Measure |
Single-arm
n=41 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Feasibility of Self-reporting Symptoms Using Moovcare®
|
66.0 percentage of e-PRO surveys completed
Standard Deviation 34
|
SECONDARY outcome
Timeframe: Baseline and at 6 monthsPopulation: Subjects who are in the study and surveyed at 6 months.
Percentage of subjects surveyed at 6 months in study satisfied with care team communication. Participant satisfaction was measured using a survey questionnaire that includes 11 mixed types of multiple-choice questions. Some questions have "yes" or "no" choices while others have multiple choices.
Outcome measures
| Measure |
Single-arm
n=33 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Patient Satisfaction
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Subjects responded to EORTC QLQ-C30 both at baseline and 6 months.
Health-related quality of life change was assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores and the mean differences between 6 months and baseline was calculated. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (1 'Very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
Single-arm
n=33 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Health-related Quality of Life Change
|
-1.01 Unite on a scale.
Standard Deviation 21.32
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Subjects responded to EORTC QLQ-LC13 questionnaire at baseline and 6 months.
Health-related quality of life lung-specific change was assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module (QLQ-LC13) scores and the mean differences between 6 months and baseline were calculated. EORTC QLQ-LC13 is a validated instrument to assess the quality of life and is composed of one multi-item scale. Possible scores range from 0 to 100; a higher score represents an increasing symptom level. A negative difference indicates quality of life improvement while a positive difference indicates worsened quality of life.
Outcome measures
| Measure |
Single-arm
n=33 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Change in Health-related Quality of Life Lung Specific
|
-1.01 Unite on a scale.
Standard Deviation 25.66
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Subjects responded the questionnaire.
Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare.
Outcome measures
| Measure |
Single-arm
n=41 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Participant Survey Completion Rate
Week 1
|
58.54 percentage of subjects
|
|
Participant Survey Completion Rate
Week 2
|
68.29 percentage of subjects
|
|
Participant Survey Completion Rate
Week 3
|
65.85 percentage of subjects
|
|
Participant Survey Completion Rate
Week 4
|
70.73 percentage of subjects
|
|
Participant Survey Completion Rate
Week 5
|
72.50 percentage of subjects
|
|
Participant Survey Completion Rate
Week 6
|
67.50 percentage of subjects
|
|
Participant Survey Completion Rate
Week 7
|
62.50 percentage of subjects
|
|
Participant Survey Completion Rate
Week 8
|
78.95 percentage of subjects
|
|
Participant Survey Completion Rate
Week 9
|
71.05 percentage of subjects
|
|
Participant Survey Completion Rate
Week 10
|
73.68 percentage of subjects
|
|
Participant Survey Completion Rate
Week 11
|
73.68 percentage of subjects
|
|
Participant Survey Completion Rate
Week 12
|
63.16 percentage of subjects
|
|
Participant Survey Completion Rate
Week 13
|
73.68 percentage of subjects
|
|
Participant Survey Completion Rate
Week 14
|
76.32 percentage of subjects
|
|
Participant Survey Completion Rate
Week 15
|
71.05 percentage of subjects
|
|
Participant Survey Completion Rate
Week 16
|
71.05 percentage of subjects
|
|
Participant Survey Completion Rate
Week 17
|
56.76 percentage of subjects
|
|
Participant Survey Completion Rate
Week 18
|
59.46 percentage of subjects
|
|
Participant Survey Completion Rate
Week 19
|
67.57 percentage of subjects
|
|
Participant Survey Completion Rate
Week 20
|
75.68 percentage of subjects
|
|
Participant Survey Completion Rate
Week 21
|
67.57 percentage of subjects
|
|
Participant Survey Completion Rate
Week 22
|
70.27 percentage of subjects
|
|
Participant Survey Completion Rate
Week 23
|
55.56 percentage of subjects
|
|
Participant Survey Completion Rate
Week 24
|
69.44 percentage of subjects
|
|
Participant Survey Completion Rate
Week 25
|
66.67 percentage of subjects
|
SECONDARY outcome
Timeframe: From time of enrollment through last contact (Up to 6 months)Population: Subjects enrolled in the study.
Overall survival will be calculated using the Kaplan-Meier method, with time starting at enrollment and ending at last contact (6 months) or death, whichever came first.
Outcome measures
| Measure |
Single-arm
n=41 Participants
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Moovcare® use: Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
|
|---|---|
|
Overall Survival
|
39 Participants
|
Adverse Events
Single-arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gita Mody
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place