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

NCT05011890 | Completed Results FDA Device

• 2 other identifiers: LCCC 205025210
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms; Cancer of Lung

Keywords

Patient Reported Outcome; Feasibility; Acceptability; Moovcare®

Outcome Measures

Primary Outcomes (1)

• Feasibility of Self-reporting Symptoms Using Moovcare®

  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.

  Up to 6 months

Secondary Outcomes (5)

• Patient Satisfaction

  Baseline and at 6 months

• Health-related Quality of Life Change

  Baseline and 6 months

• Change in Health-related Quality of Life Lung Specific

  6 months

• Participant Survey Completion Rate

  Up to 6 months

• Overall Survival

  From time of enrollment through last contact (Up to 6 months)

Study Arms (1)

Single-arm

OTHER

Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.

Device: Moovcare® use

Interventions

Moovcare® use DEVICE

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.

Single-arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Diagnosis of lung cancer (any histology, any stage) undergoing outpatient treatment and/or surveillance/monitoring at UNC.
• This may include stage I and II patients who have completed lung resection and/or are undergoing radiation, stage II and III patients receiving neoadjuvant, adjuvant, or definitive chemotherapy, stage IV patients undergoing active therapy or monitoring, patients undergoing surveillance for treated or untreated stage I-III lung cancer, and both limited and extensive small cell lung cancer. The study team will request the confirmation of the lung cancer diagnosis from the managing clinician. Patients can be enrolled at any point in their lung cancer treatment trajectory (i.e., not just at initiation of first-line treatment) after a diagnosis of lung cancer has been assigned by the treating clinician. This may include patients assigned a diagnosis of lung cancer without a tissue diagnosis.
• Speaks and understands English
• Reliable access to the internet and email
• Access to a mobile phone (or device that can receive text messages for registration)

You may not qualify if:

• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing study procedures
• Current participation in other PRO monitoring trials
• Inability to read and speak English
• Current incarceration

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Sivan Innovation Ltd.: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Stover AM, Deal AM, Medley CJ, Weiner AA, Novak L, Gentry AL, Hoch C, Weiss J, Pecot CV, Lee CB, O'Leary MC, Shrestha S, Chen H, Patel SA, Mody GN. Feasibility, Acceptability, and Utility of Remote Patient-Reported Outcomes Monitoring in Patients With Lung Cancer: A Moovcare(c) Study. Clin Lung Cancer. 2025 Dec;26(8):e660-e669.e1. doi: 10.1016/j.cllc.2025.07.016. Epub 2025 Aug 5.

  PMID: 40850860 DERIVED

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gita Mody
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

gita_mody@med.unc.edu

+1 919-966-3382

Study Officials

• Gita Mody, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single site non-randomized feasibility study. Participants on treatment and/or surveillance for new or existing diagnoses of lung cancer were assigned to monitor their patient-reported outcomes using a mobile medical application. The study population includes patients with a diagnosis of lung cancer undergoing outpatient treatment or surveillance at UNC. Patients were recruited from the Multidisciplinary Thoracic Oncology Program clinics at the University of North Carolina over 10-12 months and undergo ePRO monitoring for 6 months or until criteria for coming off study are met, whichever comes first.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single site nonrandomized feasibility study, participants on treatment and/or surveillance for new or existing diagnoses of lung cancer were assigned to a single arm involving monitoring of their patient-reported outcomes using a mobile medical application. The study population will include patients with a diagnosis of lung cancer undergoing outpatient treatment or surveillance at UNC. Patients will be recruited from the Multidisciplinary Thoracic Oncology Program (MTOP) clinics at the University of North Carolina over 10-12 months and undergo ePRO monitoring for 6 months or until criteria for coming off study are met, whichever comes first.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 18, 2021
• Study Start: September 1, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)