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

NCT ID: NCT05099679

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2024-12-20

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psychosocial intervention + Cardiac Rehab Services

Cognitive Behavioral Therapy + Cardiac Rehab

Group Type: OTHER

Cognitive behavioral therapy (supportive counseling)

Intervention Type: BEHAVIORAL

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

Virtual Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive behavioral therapy (supportive counseling)

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

Intervention Type: BEHAVIORAL

Virtual Cardiac Rehabilitation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alice Fan

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice C Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

PROS0109

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2022-02832

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-60375

Identifier Type: -

Identifier Source: org_study_id