Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 25210 | Other Grant/Funding Number | Sivan Innovation Ltd |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sivan Innovation Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Other | Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gita Mody, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40850860 | Derived | Stover AM, Deal AM, Medley CJ, Weiner AA, Novak L, Gentry AL, Hoch C, Weiss J, Pecot CV, Lee CB, O'Leary MC, Shrestha S, Chen H, Patel SA, Mody GN. Feasibility, Acceptability, and Utility of Remote Patient-Reported Outcomes Monitoring in Patients With Lung Cancer: A Moovcare(c) Study. Clin Lung Cancer. 2025 Dec;26(8):e660-e669.e1. doi: 10.1016/j.cllc.2025.07.016. Epub 2025 Aug 5. |
| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center Clinical Trials | View source |
Not provided
No plans as of now to make IPD available to other researchers.
Not provided
Not provided
Not provided
Not provided
Forty-one participants started and completed the baseline assessment and thirty- three subjects completed the six-month assessment. Participant Flow and Baseline Characteristics are based on all participants who joined the study and completed baseline assessments.
Participants were recruited from 09/01/2021 through 03/14/2022 at one cancer center in North Carolina.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm Moovcare® | Participants were assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects with lung cancer undergoing outpatient treatment and/or surveillance/monitoring and enrolled in the study and assessed per study criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PRO Collected by Moovcare | Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects enrolled in the study who started to use Moovcare and completed at least one survey questionnaire. | Posted | Mean | Standard Deviation | percentage of e-PRO surveys completed | Up to 6 months |
|
Up to 6 months
Adverse events (AEs) are defined as any untoward or unexpected events or outcomes related to or possibly related to a subject's participation in the ePROs. AEs elicited in the free text portion of the ePRO survey. Any AEs and serious AEs will be reported to the UNC IRB using the IRB's web-based reporting system and per protocol. Serious AEs are not anticipated in patients related to undergoing the use of the ePRO survey system or participating in surveys for feedback on the ePRO system.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm | Participants will be assigned to the single-arm involving weekly monitoring of their patient-reported outcomes using Moovcare®. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gita Mody | University of North Carolina Lineberger Comprehensive Cancer Center | +1 919-966-3382 | gita_mody@med.unc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | May 25, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
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.
Not provided
Not provided
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.
Not provided
|
| 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) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Subjects who are in the study and surveyed at 6 months. | Posted | Count of Participants | Participants | Baseline and at 6 months |
|
|
|
| Secondary | 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. | Subjects responded to EORTC QLQ-C30 both at baseline and 6 months. | Posted | Mean | Standard Deviation | Unite on a scale. | Baseline and 6 months |
|
|
|
| Secondary | 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. | Subjects responded to EORTC QLQ-LC13 questionnaire at baseline and 6 months. | Posted | Mean | Standard Deviation | Unite on a scale. | 6 months |
|
|
|
| Secondary | Participant Survey Completion Rate | Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare. | Subjects responded the questionnaire. | Posted | Number | percentage of subjects | Up to 6 months |
|
|
|
| Secondary | 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. | Subjects enrolled in the study. | Posted | Count of Participants | Participants | From time of enrollment through last contact (Up to 6 months) |
|
|
|
| 2 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Week 7 |
|
| Week 8 |
|
| Week 9 |
|
| Week 10 |
|
| Week 11 |
|
| Week 12 |
|
| Week 13 |
|
| Week 14 |
|
| Week 15 |
|
| Week 16 |
|
| Week 17 |
|
| Week 18 |
|
| Week 19 |
|
| Week 20 |
|
| Week 21 |
|
| Week 22 |
|
| Week 23 |
|
| Week 24 |
|
| Week 25 |
|