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

Cedars-Sinai Medical Center

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Other: Wearable Activity Monitor

Study type

Observational

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04575402

IIT2020-15-GRESH-DIGIPRO

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.