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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Cognitive behavioral therapy (supportive counseling); Behavioral: Virtual Cardiac Rehabilitation

• Registration Number: NCT05099679
• Lead Sponsor: Stanford University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-29
• Study Start: 2021-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychosocial intervention + Cardiac Rehab Services	Cognitive behavioral therapy (supportive counseling)	Cognitive Behavioral Therapy + Cardiac Rehab
Psychosocial intervention + Cardiac Rehab Services	Virtual Cardiac Rehabilitation	Cognitive Behavioral Therapy + Cardiac Rehab

Primary Outcome Measures

Name	Time	Method
Proportion of Completers	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Difference of General Anxiety Disorder-7 (GAD-7) score	12 weeks
Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score	12 weeks
Difference in Patient Health Questionnaire-9 (PHQ-9)	12 weeks

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States