NCT04575402

Brief Summary

Prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving ADT.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 19, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3.9 years

First QC Date

September 29, 2020

Last Update Submit

August 23, 2024

Conditions

Prostate Cancer

Keywords

Prostate CancerCancer survivorshipWearable technologyActivity Monitors

Outcome Measures

Primary Outcomes (2)

  • Physical function decline within 3 months from baseline

    Patient-reported physical function defined as 5-point change in standardized NIH PROMIS t-scores (mean 50, SD: 10), where higher scores represent higher physical function)

    3 months

  • Absolute change in average step counts at 3 months from baseline

    Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit as measured using a Fitbit activity monitor where mean weekly Fitbit activity values will be calculated

    3 months

Secondary Outcomes (2)

  • Mean change in Fitbit 24-hour activity

    3 months

  • Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity, as assessed in qualitative interviews.

    3 months

Study Arms (2)

CSMC prostate cancer patients receiving ADT

Prostate cancer patients recruited from oncology clinic at Cedars-Sinai Medical Center.

Other: Wearable Activity Monitor

Veterans with prostate cancer

Prostate cancer patients recruited from the Veteran Affairs Oncology Clinic (Durham, NC).

Other: Wearable Activity Monitor

Interventions

Wearable Activity MonitorOTHER

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)

Also known as: Fitbit Charge HR, Wearable tracker, Wearable biosensor
CSMC prostate cancer patients receiving ADTVeterans with prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prostate cancer patients receiving ADT (+/- radiation) being seen for treatment at Cedars-Sinai Medical Center or the VA (Durham)

You may qualify if:

  • Prostate cancer patients receiving ADT (+/- radiation) or planning to receive ADT. Start date of ADT must be planned for no more 7 days after baseline, or patients must have started ADT within 6 months prior to enrollment.
  • years or older
  • Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
  • Access to a device that has the capability to sync to the Fitbit
  • Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
  • English or Spanish speaking
  • Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if:

  • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Gillian Gresham, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

February 19, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

US(1)