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Spots Global Cancer Trial Database for Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients

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Trial Identification

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

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

Study ID: NCT04575402

Conditions

Prostate Cancer

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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gillian Gresham, PhD

Affiliation: Cedars-Sinai Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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