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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099679
• Other study ID #: IRB-60375
• Secondary ID: PROS0109NCI-2022
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Sneha Mohile
• Phone: (650) 725-5459
• Email: smohile[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in Patient Health Questionnaire-9 (PHQ-9)		12 weeks
Secondary	Difference of General Anxiety Disorder-7 (GAD-7) score		12 weeks
Secondary	Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score		12 weeks