Clinical trial NCT05099679: Pilot Study for Black Men With Prostate Cancer: Optimization Of Mental and Heart Health, the BOOM-Heart Study
Official title: A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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 \[b\]):

  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

     OR
  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 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.

Primary outcomes:
measure: Proportion of Completers
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 weeks
measure: Difference of General Anxiety Disorder-7 (GAD-7) score
timeFrame: 12 weeks
measure: Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Alice C Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: