Cancer of Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms
Conditions
Keywords
Patient Reported Outcome, Feasibility, Acceptability, Moovcare®
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.
Interventions
DEVICEMoovcare® 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.
Sponsors
Sivan Innovation Ltd.
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Self-reporting Symptoms Using Moovcare® | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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. |
| Health-related Quality of Life Change | 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. |
| Change in Health-related Quality of Life Lung Specific | 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. |
| Participant Survey Completion Rate | Up to 6 months | Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare. |
| Overall Survival | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 09/01/2021 through 03/14/2022 at one cancer center in North Carolina.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | PRO Collected by Moovcare |
|---|---|
| Age, Continuous | 61.51 years STANDARD_DEVIATION 11.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
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.
Time frame: Up to 6 months
Population: Subjects enrolled in the study who started to use Moovcare and completed at least one survey questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Feasibility of Self-reporting Symptoms Using Moovcare® | 66.0 percentage of e-PRO surveys completed | Standard Deviation 34 |
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.
Time frame: 6 months
Population: Subjects responded to EORTC QLQ-LC13 questionnaire at baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Change in Health-related Quality of Life Lung Specific | -1.01 Unite on a scale. | Standard Deviation 25.66 |
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.
Time frame: Baseline and 6 months
Population: Subjects responded to EORTC QLQ-C30 both at baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Health-related Quality of Life Change | -1.01 Unite on a scale. | Standard Deviation 21.32 |
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.
Time frame: From time of enrollment through last contact (Up to 6 months)
Population: Subjects enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-arm | Overall Survival | 39 Participants |
Secondary
Participant Survey Completion Rate
Percentage of participants who completed surveys completed at each weekly delivery time point using Moovcare.
Time frame: Up to 6 months
Population: Subjects responded the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm | Participant Survey Completion Rate | Week 10 | 73.68 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 11 | 73.68 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 1 | 58.54 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 2 | 68.29 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 3 | 65.85 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 4 | 70.73 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 5 | 72.50 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 6 | 67.50 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 7 | 62.50 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 8 | 78.95 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 9 | 71.05 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 12 | 63.16 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 13 | 73.68 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 14 | 76.32 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 15 | 71.05 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 16 | 71.05 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 17 | 56.76 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 18 | 59.46 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 19 | 67.57 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 20 | 75.68 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 21 | 67.57 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 22 | 70.27 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 23 | 55.56 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 24 | 69.44 percentage of subjects |
| Single-arm | Participant Survey Completion Rate | Week 25 | 66.67 percentage of subjects |
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.
Time frame: Baseline and at 6 months
Population: Subjects who are in the study and surveyed at 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-arm | Patient Satisfaction | 30 Participants |