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Pilot Study for Black Men With Prostate Cancer: Optimization Of Mental and Heart Health, the BOOM-Heart Study
Trial ID: 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.
A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
Inclusion Criteria for Part A (Mental Health Services)
- Self-Identify as Black and/or African American.
- Diagnosed with prostate cancer currently or any time in the past (per medical history;
pathology not required, active prostate cancer at time of enrollment is not required).
- Males >= age 18.
- All participants must have a life expectancy of > 6 months.
- Participants must have the ability to understand and the willingness to sign a written
informed consent document in English, and the willingness/ability to comply with the
- Ability to wear a face mask during all in-person sessions (when required).
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)
- Have completed the psychosocial intake portion of Visit A1 (as documented by clinical
- Meets at least one of the following ([a] or [b]):
1. planning to receive androgen deprivation on Day 1, or is currently, or was
formerly, on androgen deprivation therapy. It is acceptable for participant to
switch/transition to another form of androgen deprivation therapy while in the
study. Participant may be receiving or planning to receive additional systemic
therapy concurrent with androgen deprivation.
^ treatment with single agent testosterone-blocking agents (such as, but not
limited to bicalutamide) will also be eligible
2. patients with a cardiac risk factor may enroll. Cardiac risk factors include, but
are not restricted to: pre-hypertension, hypertension, metabolic syndrome,
tobacco history, coronary artery disease, CVA/TIA, peripheral vascular disease,
obesity, hypercholesterolemia, hyperglycemia, heart failure, or any other cardiac
condition based on the discretion of the investigators.
- Participants must have an ECOG Performance Status of <= 2 or at the investigator's
discretion, will have the ability to participate in a cardiac rehab program.
- Participants must be able and willing to follow the cardiac rehabilitation activities.
- Participant must have a smartphone or tablet to use for the cardiac rehabilitation
Exclusion Criterion for Part A (Mental Health Services)
* Actively engaging in self harm, or currently on a 5150 or 5250.
Exclusion Criteria for Part B (Cardiac Services)
- Uncontrolled angina, active acute coronary syndrome (e.g., unstable angina or acute
MI) or poorly controlled arrhythmias.
- In the opinion of the Principal Investigator, have a clinically significant comorbid
disease that is likely to affect the ability of the patient to complete the trial,
interfere with their ability with measurement of self-reported outcomes.
behavioral: Cognitive behavioral therapy (supportive counseling)
behavioral: Virtual Cardiac Rehabilitation
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