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

NCT ID: NCT06703996

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-05-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Discussion

Intervention Type OTHER

Participate in check-in/goal-setting discussions

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear the InBody Band 3 fitness tracker

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Discussion

Participate in check-in/goal-setting discussions

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear the InBody Band 3 fitness tracker

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Discuss

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Emma Fortune Ngufor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma Fortune Ngufor, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2024-09282

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-009203

Identifier Type: OTHER

Identifier Source: secondary_id

24-009203

Identifier Type: -

Identifier Source: org_study_id

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