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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

Up to 6 months

Results posted on

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

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: Subjects responded the questionnaire.

Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare.

Outcome measures

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

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 events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

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

Phone: +1 919-966-3382

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place