Survivor mHealth: Wearable Devices in Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cancer
• Intervention / Treatment: Behavioral: Wearable device deployment

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
3-month Daily Step Count	The mean number of steps taken per day during week 12 of the intervention.	At study completion, within 3-months of enrollment
1-Month Usability Overall APP Rating	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.	1-month post-enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Communication; Wearable
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: H00023545; 5P50CA244693-02 (U.S. NIH Grant/Contract); 1K12HL138049-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No