Pilot Study for Black Men With Prostate Cancer: Optimization Of Mental and Heart Health, the BOOM-Heart Study


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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.

Official Title

A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer

Stanford Investigator(s)

Alice C. Fan
Alice C. Fan

Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology

Han Zhu
Han Zhu

Assistant Professor of Medicine (Cardiovascular Medicine)


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
   protocol activities.

   - 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
   social worker).

   - 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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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sneha Mohile

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