Survivor mHealth: Wearable Devices in Cancer Survivors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Wearable device deployment Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. |
Behavioral: Wearable device deployment
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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility of enrollment [Baseline]
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.
Secondary Outcome Measures
- Changes in objective physical activity [At study completion, within 3-months of enrollment]
Change from baseline to 3-months in steps, light, moderate and vigorous physical activity measured via Fitbits.
- Changes in self-report physical activity [At study completion, within 3-months of enrollment]
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.
- Changes in quality of life [At study completion, within 3 months of referral completion]
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.
- Usability [1-month and 3-months post-enrollment]
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 Usability [1-month post-enrollment]
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-Month Usability [3-months post-enrollment]
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.
- Participant program acceptability [At study completion, within 3 months of referral completion]
Qualitative feedback from enrolled participants on the acceptability of the Fitbits, app, mobile questionnaires, and push notification messages within the app
Other Outcome Measures
- Provider acceptability of wearable devices and preferences to receive data [At study completion; Within 3-month of last patient enrolled]
Qualitative feedback from providers on their preferences for patients using wearable devices and receiving patient-generated data
Eligibility Criteria
Criteria
Aims 1 and 2 Inclusion Criteria:
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Past cancer diagnosis
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At least 18 years of age
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Capacity to provide informed consent
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Medically cleared to perform physical activity (as noted by Physical Activity Readiness Questionnaire form or physician's clearance if needed)
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Owns a smartphone
Aims 1 and 2 Exclusion Criteria:
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Is a prisoner
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Non-English speaking
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Is unable to provide consent
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Under 18 years of age
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No prior cancer diagnosis
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Does not own a smartphone
Aim 3 Inclusion Criteria:
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Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist
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Consent to participate
Aim 3 Exclusion Criteria:
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Not currently employed at UMass Memorial
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Not involved in direct treatment of care coordination of cancer patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Massachusetts Chan Medical School | Worcester | Massachusetts | United States | 01605 |
Sponsors and Collaborators
- University of Massachusetts, Worcester
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Jamie M Faro, PhD, University of Massachusetts Chan Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H00023545
- 5P50CA244693-02
- 1K12HL138049-01