Stanford University
Palo Alto, California, 94305, United States
NCT Number: NCT05099679
Pilot study to determine the feasibility of providing psychosocial and cardiac rehabilitation services to address socioeconomic health disparities and improve wellbeing for black men with prostate cancer.
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Notify Me18 year and older
Male
Interventional
Not applicable
Palo Alto, California, 94305, United States
Subjects will see an oncology Associate Clinical Social Worker at Stanford's Cancer Center for a two hour psychosocial assessment. Subsequently participants will complete the psychosocial intake support session and elective additional counseling sessions (Part A) at the end of up to 8 counseling sessions (maximum sessions possible) or 20 weeks (+/- 4 weeks), whichever comes first. For participants who continue onto cardiac services (Part B), the participant will complete the cardiac rehabilitation exercise program within 12 weeks (+/- 2 weeks) of the first day of exercise start. The end of study will occur after the last cardiac rehabilitation exercise session (+ 2 weeks).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Part A (Mental Health Services)
Participants must complete the psychosocial intake (Part A, Visit A1) in order to enroll in a cardiac rehabilitation program (Part B).
Additional Inclusion Criteria for Part B (Cardiac Services)
^ treatment with single agent testosterone-blocking agents (such as, but not limited to bicalutamide) will also be eligible
OR
Exclusion Criterion for Part A (Mental Health Services)
Exclusion criteria
for Part B (Cardiac Services)
Patients will complete a psychosocial intake that generally takes up to 2 hours, but the time required for the intake varies per patient. Subsequently they will be offered up to 7 optional counseling sessions with a clinical social worker
If eligible, patients will be referred to Movn Health Virtual Cardiac Rehabilitation to provide approximately 3 exercise sessions per week, with approximately eight coaching sessions over a 12 week period
Time frame: 12 weeks
Proportion of screened eligible participants who complete the initial 2-hour psychosocial support session intake.
The pilot study is considered feasible if the primary endpoint is met in at least 50% of patients. We will evaluate the 95% CI of the feasibility rate.
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Stanford University
Other
A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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