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

Primary Purpose

Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moovcare® use
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer focused on measuring Patient Reported Outcome, Feasibility, Acceptability, Moovcare®

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Participant Survey Completion Rate
Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare.
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.

Full Information

First Posted
July 26, 2021
Last Updated
October 5, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Sivan Innovation Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05011890
Brief Title
Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
Acronym
LC-PRO
Official Title
Feasibility and Acceptability of Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
October 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Sivan Innovation Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Cancer of Lung
Keywords
Patient Reported Outcome, Feasibility, Acceptability, Moovcare®

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm
Arm Type
Other
Arm Description
Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®.
Intervention Type
Device
Intervention Name(s)
Moovcare® use
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of Self-reporting Symptoms Using Moovcare®
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
Baseline and at 6 months
Title
Health-related Quality of Life Change
Description
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.
Time Frame
Baseline and 6 months
Title
Change in Health-related Quality of Life Lung Specific
Description
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.
Time Frame
6 months
Title
Participant Survey Completion Rate
Description
Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare.
Time Frame
Up to 6 months
Title
Overall Survival
Description
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.
Time Frame
From time of enrollment through last contact (Up to 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gita Mody, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans as of now to make IPD available to other researchers.
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
UNC Lineberger Comprehensive Cancer Center Clinical Trials

Learn more about this trial

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

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