Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04575402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-27
First Post:
2020-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DigiPRO
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: