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

Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Fitbit 24-hour activity	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	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.	This is a qualitative endpoint assessed in individual patient interviews at end of study.	3 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Gillian Gresham, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer; Cancer survivorship; Activity Monitors; Wearable technology
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IIT2020-15-GRESH-DIGIPRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No