Survivor mHealth: Wearable Devices in Cancer Survivors

Not Applicable

Completed

• Conditions: Cancer; Cardiovascular Diseases
• Interventions: Behavioral: Wearable device deployment

• Registration Number: NCT05417438
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-14
• Study Start: 2023-01-15
• Primary Completion: 2023-09-30
• Status Verified: 2023-10
• Study Completion: 2023-10-15
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wearable device deployment	Wearable device deployment	Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
3-month Daily Step Count	At study completion, within 3-months of enrollment	The mean number of steps taken per day during week 12 of the intervention.
1-Month Usability Overall APP Rating	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". The mean was taken from the overall app usability question and reported. A higher score indicates greater user acceptability of the app. The lowest possible score is a 1, and the highest possible score is a 5.

Trial Locations

Locations (1)

University of Massachusetts Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States