Survivor mHealth: Wearable Devices in Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05417438
• Other study ID #: H00023545
• Secondary ID: 5P50CA244693-021
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 15, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Aims 1 and 2 Inclusion Criteria:

1. Past cancer diagnosis

2. At least 18 years of age

3. Capacity to provide informed consent

4. Medically cleared to perform physical activity (as noted by Physical Activity Readiness Questionnaire form or physician's clearance if needed)

5. Owns a smartphone

Aims 1 and 2 Exclusion Criteria:

1. Is a prisoner

2. Non-English speaking

3. Is unable to provide consent

4. Under 18 years of age

5. No prior cancer diagnosis

6. Does not own a smartphone

Aim 3 Inclusion Criteria:

1. Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist

2. Consent to participate

Aim 3 Exclusion Criteria:

1. Not currently employed at UMass Memorial

2. Not involved in direct treatment of care coordination of cancer patients

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Provider acceptability of wearable devices and preferences to receive data	Qualitative feedback from providers on their preferences for patients using wearable devices and receiving patient-generated data	At study completion; Within 3-month of last patient enrolled
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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