Prostate CarcinomaNCT06703996
InBody Band 3 Fitness Tracker to Improve Health Outcomes and Quality of Life in Black Prostate Cancer Survivors
A study testing Discussion, Medical Device Usage and Evaluation and Questionnaire Administration in people with Prostate Carcinoma, run by Mayo Clinic at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Discussion, Medical Device Usage and Evaluation and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2024to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Prostate Carcinoma
- Being tested
- Discussion, Medical Device Usage and Evaluation, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionOther
Also called Discuss
Participate in check-in/goal-setting discussions
Medical Device Usage and EvaluationOther
Wear the InBody Band 3 fitness tracker
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (InBody Band 3 fitness tracker) | Experimental | 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. Receives: Other: Discussion; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start4 Nov 2024
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Fortune Ngufor, Mayo Clinic
- Investigators
- Emma Fortune Ngufor, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703996
- Sponsor's protocol ID
- 24-009203
- Other IDs
- NCI-2024-09282, 24-009203
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Digital Divide of Wearables to Improve Health Outcomes and Quality of Life Among Black Prostate Cancer (CaP) Survivors
- ClinicalTrials.gov ID
- NCT06703996
- Acronym / sponsor ID
- 24-009203
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (InBody Band 3 fitness tracker) | Experimental | Other: Discussion, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussParticipate in check-in/goal-setting discussions | Other | Supportive care (InBody Band 3 fitness tracker) |
| Medical Device Usage and EvaluationWear the InBody Band 3 fitness tracker | Other | Supportive care (InBody Band 3 fitness tracker) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (InBody Band 3 fitness tracker) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Fortune Ngufor, PhD principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Medical Device Usage and Evaluation and Questionnaire Administration in people with Prostate Carcinoma, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.