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

NCT ID: NCT04575402

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2024-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CSMC prostate cancer patients receiving ADT

Prostate cancer patients recruited from oncology clinic at Cedars-Sinai Medical Center.

Wearable Activity Monitor

Intervention Type: OTHER

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)

Veterans with prostate cancer

Prostate cancer patients recruited from the Veteran Affairs Oncology Clinic (Durham, NC).

Wearable Activity Monitor

Intervention Type: OTHER

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

Fitbit Charge HR; Wearable tracker; Wearable biosensor

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gillian Gresham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gillian Gresham, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2020-15-GRESH-DIGIPRO

Identifier Type: -

Identifier Source: org_study_id