InBody Band 3 Fitness Tracker to Improve Health Outcomes and Quality of Life in Black Prostate Cancer Survivors

Mayo Clinic

Status: Enrolling

Conditions: Prostate Carcinoma

Treatments: Other: Discussion; Other: Questionnaire Administration; Other: Medical Device Usage and Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06703996

NCI-2024-09282 (Registry Identifier)

24-009203 (Other Identifier)

Details and patient eligibility

About

This clinical trial studies how well the InBody Band 3 fitness tracker works to improve physical activity, body composition, and quality of life in Black prostate cancer survivors. Prostate cancer is the most common cancer in men and Black men are more likely to be diagnosed with prostate cancer in an advanced stage. Body composition is associated with disease progression, treatment response, and survival in cancer patients. Reducing stress and maintaining healthy levels of physical activity and sleep are important for a healthy body and improving outcomes, however, there is currently little evidence available on the physical activity, stress levels and sleep patterns in this population. Wearable health activity trackers and smart watches are tools that can be used to track physical activity, stress, sleep and body composition and have been shown to have a positive impact in many patient populations. The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer survivors.

Full description

PRIMARY OBJECTIVES:

I. Assess the feasibility of a remote wearables-based intervention among Black prostate cancer survivors.

II. Assess the acceptability of the wearables-based intervention among Black prostate cancer survivors.

OUTLINE:

Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to read/speak English and are able to communicate by phone
• 18 years of age or older
• Self-identify as Black
• Have been diagnosed with stage I-IV prostate cancer
• Have an active email address and are able to regularly check emails for electronic surveys
• Own and are willing to use a personal smartphone with regular/reliable access to the internet to sync regularly with a fitness tracker
• Are willing to wear and use a smart fitness tracker for 6 weeks and allow sharing of their fitness data with the study team
• Are not currently undergoing adjunct cancer therapy (e.g. chemotherapy, radiation) during the 6 weeks of study participation, except oral tyrosine kinase inhibitor or hormonal therapies; and
• Are an existing Mayo patient
• Self-report that they would like to improve their physical activity during initial study coordinator contact

Exclusion criteria

• Live outside of the United States (U.S)
• Have an implanted medical device (e.g., pacemaker, etc.) or a life-sustaining device (e.g., patient monitoring device)
• Have a self-reported history of a psychiatric disorder(s) or moderate to severe cognitive impairment precluding participation in the study intervention or preventing the ability to provide independent informed consent
• Are on prolonged bed rest (i.e., more than half of the waking day in bed) by self-report
• Currently have any lower extremity injury that impedes them from engaging in walking for one block
• Are unable to walk for at least one block without a walking aide by self-report; or
• Regularly use a wheelchair for mobility by self-report

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Supportive care (InBody Band 3 fitness tracker)

Experimental group

Description:

Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Questionnaire Administration

Other: Discussion