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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male (biologic sex), aged ≥18 years of age

Diagnosis of prostate cancer

Disqualifiers

Wrist circumference less than 95 mm or greater than 222 mm

Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone

Presence of VMS prior to initiation of ADT, regardless of severity or duration

Active febrile illness (temperature >38°C) or on active treatment for febrile illness

Trial design

Design model

Single group

Treatments tested in this trial

  • VMS logging

    Behavioral

    Wearing of smartwatch and logging VMS

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Smartwatch for VMS LoggingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Duration of wear per day

For each participant, we will calculate the duration of device wear for each day using the real-time data recorded by the device and estimate the mean daily duration.

Time frame
28 days
2

Percent of days with self-reported time marked vasomotor events

Percent of days with self-reported time marked vasomotor events, using the real-time marked vasomotor events from the device.

Time frame
28 days
3

Concordance between time marked vasomotor events and events described through EMAs.

Concordance between time marked vasomotor events and EMA reporting of vasomotor events during the corresponding time period.

Time frame
28 days

Secondary outcomes

1

Number of participants who complete the post-intervention visit

Number of participants who complete the post-intervention visit

Time frame
28 days
2

Post intervention survey

Post intervention survey

Time frame
28 days

Other outcomes

Sponsors and contacts

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