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

Prostate Cancer Clinical Trial

— DigiPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575402
• Other study ID #: IIT2020-15-GRESH-DIGIPRO
• Status: Recruiting
• Start date: February 19, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Cedars-Sinai Medical Center
• Contact: Gillian Gresham, PhD
• Phone: 310-423-3341
• Email: Gillian.Gresham[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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