Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare® (LC-PRO)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Neoplasms, Lung; Pulmonary Neoplasms; Neoplasms, Pulmonary; Pulmonary Cancer; Cancer of Lung
• Intervention / Treatment: Device: Moovcare® use

Detailed Description

This is a single site nonrandomized feasibility study of approximately 50 participants on treatment and/or surveillance for new or existing diagnoses of lung cancer who will be assigned to a single-arm involving monitoring of their patient-reported outcomes using a mobile medical application. The study procedures include monitoring of patient symptoms using automated weekly PRO surveys delivered by Moovcare® and assessment of outcomes including quality of life at baseline and at monthly intervals, as well as patient satisfaction at 6 months. The clinical care team will receive an alert if the PRO survey suggests increased or worsening symptoms. The care team will follow their usual protocols for the management of symptoms. The patient clinical information will also be abstracted from the medical record to assess clinical outcomes. The provider's satisfaction survey will be assessed via surveys.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years or older

2. 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.

3. Speaks and understands English
4. Reliable access to the internet and email
5. Access to a mobile phone (or device that can receive text messages for registration)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	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.	Baseline and at 6 months
Health-related Quality of Life Change	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.	Baseline and 6 months
Change in Health-related Quality of Life Lung Specific	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.	6 months
Participant Survey Completion Rate	Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare.	Up to 6 months
Overall Survival	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.	From time of enrollment through last contact (Up to 6 months)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Sivan Innovation Ltd.
• Investigators: Principal Investigator: Gita Mody, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Acceptability; Patient Reported Outcome; Moovcare®
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LCCC 2050; 25210 (Other Grant/Funding Number: Sivan Innovation Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans as of now to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes