DigiPRO: Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04575402
Collaborator
United States Department of Defense (U.S. Fed)
40
Enrollment
1
Location
22.3
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Wearable Activity Monitor

Detailed Description

Physical function is a known predictor of QOL in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with Androgen Deprivation Therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors
Actual Study Start Date :
Feb 19, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
CSMC prostate cancer patients receiving ADT

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

Other: Wearable Activity Monitor
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)
Other Names:
  • Fitbit Charge HR
  • Wearable tracker
  • Wearable biosensor
  • Veterans with prostate cancer

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

    Other: Wearable Activity Monitor
    Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)
    Other Names:
  • Fitbit Charge HR
  • Wearable tracker
  • Wearable biosensor
  • Outcome Measures

    Primary Outcome Measures

    1. Physical function decline within 3 months from baseline [3 months]

      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)

    2. Absolute change in average step counts at 3 months from baseline [3 months]

      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

    Secondary Outcome Measures

    1. Mean change in Fitbit 24-hour activity [3 months]

      Change will be calculated based on difference in 24 hour activity as defined as periods of active minutes, sedentary time, and sleep at baseline and end-of-study

    2. 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]

      This is a qualitative endpoint assessed in individual patient interviews at end of study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.

    • 18 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.

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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Cedars Sinai Medical CenterLos AngelesCaliforniaUnited States90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center
    • United States Department of Defense

    Investigators

    • Principal Investigator: Gillian Gresham, PhD, Cedars-Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gillian Gresham, Assistant Professor, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT04575402
    Other Study ID Numbers:
    • IIT2020-15-GRESH-DIGIPRO
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gillian Gresham, Assistant Professor, Cedars-Sinai Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2021