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NCT Number: NCT05011890

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.

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Key information

Conditions

Lung Cancer Cancer of Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Self-reporting Symptoms Using Moovcare®

    Time frame: 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.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 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.

  2. Health-related Quality of Life Change

    Time frame: 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-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.

  3. Change in Health-related Quality of Life Lung Specific

    Time frame: 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 life.

  4. Participant Survey Completion Rate

    Time frame: Up to 6 months

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

  5. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Sivan Innovation Ltd.

Registry information

Official study title

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

Acronym: LC-PRO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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