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

NCT05099679 | Completed

• 3 other identifiers: IRB-60375PROS0109NCI-2022-02832
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Psychosocial intervention + Cardiac Rehab Services

OTHER

Cognitive Behavioral Therapy + Cardiac Rehab

Behavioral: Cognitive behavioral therapy (supportive counseling); Behavioral: Virtual Cardiac Rehabilitation

Interventions

Cognitive behavioral therapy (supportive counseling) 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

Psychosocial intervention + Cardiac Rehab Services

Virtual Cardiac Rehabilitation 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

Psychosocial intervention + Cardiac Rehab Services

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-Identify as Black and/or African American
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[b\]):
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alice C Fan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Oncology) and, by courtesy, of Urology

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 29, 2021
• Study Start: November 18, 2021
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)