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

Study 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).

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral therapy (supportive counseling)
* Behavioral: Virtual Cardiac Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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]): 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 OR 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 app. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Psychosocial intervention + Cardiac Rehab Services<br>Cognitive Behavioral Therapy + Cardiac Rehab | Behavioral: Cognitive behavioral therapy (supportive counseling)<br>* 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<br>Behavioral: Virtual Cardiac Rehabilitation<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Completers | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Patient Health Questionnaire-9 (PHQ-9) |  | 12 weeks | 
| Difference of General Anxiety Disorder-7 (GAD-7) score |  | 12 weeks | 
| Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score |  | 12 weeks |