Clinical trial NCT05011890: Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
Official title: Feasibility and Acceptability of Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Cancer of Lung
Keywords: Patient Reported Outcome
Feasibility
Acceptability
Moovcare®
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Sivan Innovation Ltd.
First posted: 2021-08-18
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Self-reporting Symptoms Using Moovcare®
timeFrame: Up to 6 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Baseline and at 6 months
measure: Health-related Quality of Life Change
timeFrame: Baseline and 6 months
measure: Change in Health-related Quality of Life Lung Specific
timeFrame: 6 months
measure: Participant Survey Completion Rate
timeFrame: Up to 6 months
measure: Overall Survival
timeFrame: From time of enrollment through last contact (Up to 6 months)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gita Mody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: