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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05011890

Collaborator

Sivan Innovation Ltd. (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Cancer of Lung	Device: Moovcare® use	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model 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 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.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 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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility of self-reporting symptoms by lung cancer patients using Moovcare® [At 6 months]
Mean percentage of e-PRO surveys completed per patient by 6 months or coming off study per protocol if sooner.

Secondary Outcome Measures

Patient satisfaction [baseline and at 6 months]
Percentage of patients surveyed at 6 months on study satisfied with care team communication.
Health-related quality of life (QLQ-C30) [6 months]
EORTC QLQC30 is a validated instrument to assess quality of life and is composed of multi-item scales and single-item measures. Possible scores ranges from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. Change = (6 months score - Baseline)
Health-related quality of life (QLQ-LC13) [6 months]
EORTC QLQ-LC13 is a validated instrument to assess quality of life and is composed of one multi-item scale. Possible scores ranges from 0 to 100; a higher score represents an increasing symptom level. Change = (6 months score - Baseline)
Survey completion [Moovcare enrollment through the end of study participation (6months)]
Percentage of surveys completed at each weekly delivery time point
Overall survival [From time of enrollment through last contact (6 months)/date of death, whichever came first]
Overall survival will be calculated using the Kaplan Meier method, with time starting at enrollment, and ending at last contact (6 months) or date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 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)

Exclusion Criteria:

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