Survivor mHealth: Wearable Devices in Cancer Survivors

Study Overview
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Brief Summary
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The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits) and a smartphone application in cancer survivors. The goal of the program is to increase survivor's physical activity levels. The Fitbit will be synced to the app and participants will receive messages and notifications about their activity levels. Participants will also complete surveys through the app asking how useful it is and ways to improve it. The study team will conduct qualitative interviews at the completion of the 3 months to see how participants liked the program, and ways it can be improved and make it more specific to cancer survivors. The study team will also conduct interviews with providers and clinic staff to assess their perceptions of patient digital health programs and preferences for receiving patient-generated health data.

Official Title
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Survivor mHealth: Assessing Feasibility of a Wearable Device and App in Cancer Survivors

Conditions
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Cancer, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Wearable device deployment


Participation Criteria
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Eligibility Criteria
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Aims 1 and 2 Inclusion Criteria: Past cancer diagnosis At least 18 years of age Capacity to provide informed consent Medically cleared to perform physical activity (as noted by Physical Activity Readiness Questionnaire form or physician's clearance if needed) Owns a smartphone Aims 1 and 2 Exclusion Criteria: Is a prisoner Non-English speaking Is unable to provide consent Under 18 years of age No prior cancer diagnosis Does not own a smartphone Aim 3 Inclusion Criteria: Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist Consent to participate Aim 3 Exclusion Criteria: Not currently employed at UMass Memorial Not involved in direct treatment of care coordination of cancer patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable device deployment<br>Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. | Behavioral: Wearable device deployment<br>* Participants will receive a Fitbit to be synced with a smartphone app (MyDataHelps). Participants will receive push notifications to complete surveys via the MyDataHelps app. The Fitbit will sync with the app for data collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of enrollment | Feasibility will be determined by a participant meeting all three criteria: 1) Enrollment in trial, 2) completion of baseline measures, and 3) Fitbit sync to app. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in objective physical activity | Change from baseline to 3-months in steps, light, moderate and vigorous physical activity measured via Fitbits. | At study completion, within 3-months of enrollment | 
| Changes in self-report physical activity | Change from baseline to 3-months in light, moderate and vigorous physical activity survey-measured (Godin leisure time questionnaire) physical activity. The questionnaire is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous leisure-time physical activity bouts of at least 15 min duration in a typical week. Scores can range from 0 to 98, with the higher score meaning a greater level of activity for that week. | At study completion, within 3-months of enrollment | 
| Changes in quality of life | The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire assessing physical, emotional, social, and functional well-being over the past 7 days. Participants respond on a Likert scale of 0 to 4 (0=Not at all, 4=Very much). Scores are summed to a total of 0-108 points, with a higher score indicating a greater quality of life. | At study completion, within 3 months of referral completion | 
| Usability | Mobile Application Rating Scale (MARS). The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from 1.Inadequate to 5.Excellent. A higher score indicates greater user acceptability of the app. | 1-month and 3-months post-enrollment | 
| 1-Month Usability | Mobile Application Rating Scale (MARS). The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from 1.Inadequate to 5.Excellent. A higher score indicates greater user acceptability of the app. | 1-month post-enrollment | 
| 3-Month Usability | Mobile Application Rating Scale (MARS). The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from 1.Inadequate to 5.Excellent. A higher score indicates greater user acceptability of the app. | 3-months post-enrollment | 
| Participant program acceptability | Qualitative feedback from enrolled participants on the acceptability of the Fitbits, app, mobile questionnaires, and push notification messages within the app | At study completion, within 3 months of referral completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Wearable, Communication