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Exercise Intervention among Men with Prostate Cancer Initiating Androgen Deprivation Therapy: Pilot Study

Not Enrolling

Trial ID:NCT03070145

View complete trial on ClinicalTrials.gov

Protocol #:16-515

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer

Phase:Feasibility / Pilot

Principal Investigator:Nguyen, Paul, L

Site Investigator(s):Nguyen, Paul, L.

Trial Description:
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer

Eligibility Requirements:
- Written informed consent prior to any study-related procedures
- History of histologically confirmed prostate cancer
- Initiating or within 30 days of initiating ADT
- ECOG performance status of 0 or 1
- At least 18 years old and no older than 80 years
- Physically able to exercise and have physician consent from their treating physician to start a physical activity program
- English speaking and able to read English
- Have access to and are able to use the internet at a minimum of once per week
- Sufficient proficiency and confidence to use the internet and follow video-based instructions, as determined by the eligibility questionnaire to be completed by the participant
- Willingness to be randomized
Exclusion Criteria:
- Self-reported inability to walk 2 blocks (at any pace)
- Currently physically active (> 90 minutes of moderate or vigorous physical activity per week) as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI])
- Previously on ADT
- Radiologic evidence of distant disease
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)

Protocol #: 16-515

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)