NCT05011890: LC-PRO

Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®

Completed NA Results posted Last updated 10 October 2023

What this trial tests

NA trial testing Moovcare® use in Lung Cancer in 41 participants. Completed in 6 October 2022.

Timeline

1 September 2021

Primary endpoint
6 October 2022

6 October 2022

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	41
Start date	1 September 2021
Primary completion	6 October 2022
Estimated completion	6 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Moovcare® use

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Neoplasms, Lung — all drugs for Neoplasms, Lung →
• Neoplasms, Pulmonary — all drugs for Neoplasms, Pulmonary →
• Pulmonary Cancer — all drugs for Pulmonary Cancer →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

Adults 18 to 99, any sex, with Lung Cancer or Neoplasms, Lung. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Self-reporting Symptoms Using Moovcare® Primary · Up to 6 months

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.

Group	Value	95% CI
Single-arm	66.0	± 34

Patient Satisfaction Secondary · Baseline and 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.

Group	Value	95% CI
Single-arm	30

Health-related Quality of Life Change Secondary · 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-

Group	Value	95% CI
Single-arm	-1.01	± 21.32

Change in Health-related Quality of Life Lung Specific Secondary · 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

Group	Value	95% CI
Single-arm	-1.01	± 25.66

Participant Survey Completion Rate Secondary · Up to 6 months

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

Week 1

Group	Value	95% CI
Single-arm	58.54

Week 2

Group	Value	95% CI
Single-arm	68.29

Week 3

Group	Value	95% CI
Single-arm	65.85

Week 4

Group	Value	95% CI
Single-arm	70.73

Week 5

Group	Value	95% CI
Single-arm	72.50

Week 6

Group	Value	95% CI
Single-arm	67.50

Week 7

Group	Value	95% CI
Single-arm	62.50

Week 8

Group	Value	95% CI
Single-arm	78.95

Overall Survival Secondary · From time of enrollment through last contact (Up to 6 months)

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.

Group	Value	95% CI
Single-arm	39

Sponsor's own description

The purpose of this study is to demonstrate how Moovcare®, a mobile medical application, can be used to monitor Patient-Reported Outcomes (PROs) related to cancer treatment, cancer complications, and cancer relapse in patients with lung cancer. PROs are symptoms directly reported by patients through the completion of a survey. Up to 50 patients undergoing treatment and/or surveillance for new or existing diagnoses of lung cancer at the University of North Carolina's Lineberger Comprehensive Cancer Center will be prospectively enrolled to the use of the mobile medical application Moovcare® for 6 months. Moovcare® is not FDA approved, and its role in improving clinical care is being studied through this research. Moovcare® automatically delivers electronic patient reported outcome (ePRO) surveys on common symptoms experienced by lung cancer patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility, Acceptability, and Utility of Remote Patient-Reported Outcomes Monitoring in Patients With Lung Cancer: A Moovcare© Study.
   Stover AM, Deal AM, Medley CJ, Weiner AA, et al · · 2025 · PMID 40850860 · DOI 10.1016/j.cllc.2025.07.016