Survivor mHealth: Wearable Devices in Cancer Survivors

NCT ID: NCT05417438

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-10-15

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.

Conditions

Cancer; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Wearable device deployment

Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app.

Group Type: EXPERIMENTAL

Wearable device deployment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

2. Consent to participate

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

1. Not currently employed at UMass Memorial

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Jamie Faro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie M Faro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Locations

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5P50CA244693-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1K12HL138049-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00023545

Identifier Type: -

Identifier Source: org_study_id