A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (Prostate 007)

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07535541
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VMS logging — BEHAVIORAL
    Wearing of smartwatch and logging VMS

Study Details

The purpose of this study is to find out if patients with prostate cancer who have vasomotor symptoms, commonly called hot flashes, from their Androgen Deprivation Therapy (ADT) will consistently wear a smartwatch device to track their health data, log hot flashes on their smartwatch, and how these data compare with daily surveys about their hot flashes. Participants will be asked to wear the smartwatch for 4 weeks and to log their hot flashes on their smart watch pressing a button on the watch. Participants will be asked to complete surveys (sent through a text message link) to describe their experiences with hot flashes.

Key Dates

Start date
May 21, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Smartwatch for VMS Logging
    Participants will be asked to wear a smartwatch during daily life and log VMS events by pressing a designated button on a smartwatch device. Participants will be asked to wear the watch for the duration of the study. Participants will receive daily electronic (Ecological Momentary Assessments) EMAs from the UVA Qualtrics platform via text message link. EMAs are used to record VMS frequency and subjective experiences.

Primary Outcome Measure

Duration of wear per day [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Health SystemCharlottesvilleVirginia22908-

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