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

Bridging the Digital Divide of Wearables to Improve Health Outcomes and Quality of Life Among Black Prostate Cancer (CaP) Survivors

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.

Study Overview

• Status: Completed
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Discussion; Other: Medical Device Usage and Evaluation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Supportive care (InBody Band 3 fitness tracker); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Discussion; Participate in check-in/goal-setting discussions; Other Names: Discuss; Other: Medical Device Usage and Evaluation; Wear the InBody Band 3 fitness tracker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate	The adherence rate will be calculated as the ratio of number of valid data collection weeks to the number of expected valid data collection weeks for each participant. A group average adherence rate of 80% will be considered feasible.	Up to 6 weeks
Change in acceptability scale score	Will be assessed using the 6-item Acceptability survey for physical activity interventions. Participants will be asked to rate each question from 0 (not at all) to 10 (extremely), and a mean score will be calculated. An average group rating of 8.0 or higher on a 10-point scale will be required to determine intervention acceptability. Change in score will be defined as the final intervention week's value minus the first week's value.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Emma Fortune Ngufor, PhD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 24-009203 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-09282 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No