Clinical trial NCT06703996: InBody Band 3 Fitness Tracker to Improve Health Outcomes and Quality of Life in Black Prostate Cancer Survivors
Official title: Bridging the Digital Divide of Wearables to Improve Health Outcomes and Quality of Life Among Black Prostate Cancer (CaP) Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence rate
timeFrame: Up to 6 weeks
measure: Change in acceptability scale score
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Emma Fortune Ngufor, PhD
role: PRINCIPAL_INVESTIGATOR
References: