Clinical trial NCT04575402: 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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Cancer survivorship
Wearable technology
Activity Monitors
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-10-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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 criteria: 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.

Primary outcomes:
measure: Physical function decline within 3 months from baseline
timeFrame: 3 months
measure: Absolute change in average step counts at 3 months from baseline
timeFrame: 3 months
Secondary outcomes:
measure: Mean change in Fitbit 24-hour activity
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Gillian Gresham, PhD
role: PRINCIPAL_INVESTIGATOR
References: