A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Stanford University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Proportion of Completers
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Alice Fan
Associate Professor of Medicine (Oncology) and, by courtesy, of Urology
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of Completers
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.
Secondary Outcomes
- Difference of General Anxiety Disorder-7 (GAD-7) score(12 weeks)
- Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score(12 weeks)
- Difference in Patient Health Questionnaire-9 (PHQ-9)(12 weeks)