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Completed

NCT Number: NCT06703996

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

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discussion

Other

Participate in check-in/goal-setting discussions

Other names: Discuss

Medical Device Usage and Evaluation

Other

Wear the InBody Band 3 fitness tracker

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Adherence rate

    Time frame: Up to 6 weeks

    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.

  2. Change in acceptability scale score

    Time frame: Up to 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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