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Psychosocial intervention + Cardiac Rehab Services for Prostate Cancer
N/A
Recruiting
Led By Alice Fan, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males >= age 18
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trialseeks to improve wellbeing of black men with prostate cancer by providing tailored rehabilitation services to address social & medical issues.
Who is the study for?
This trial is for Black men over 18 with prostate cancer, who are on androgen deprivation therapy or may start it. They should be able to wear a mask, have an ECOG status of <=2, expect to live more than 6 months, understand English consent forms, and use a cardiac rehab app. Excluded are those self-harming or with uncontrolled heart issues.Check my eligibility
What is being tested?
The BOOM-Heart Study tests if psychosocial support through cognitive behavioral therapy and virtual cardiac rehabilitation can improve mental and heart health in Black men with prostate cancer while addressing health disparities.See study design
What are the potential side effects?
Since the interventions involve counseling and exercise programs rather than drugs, side effects might include emotional discomfort from therapy discussions or physical strain from new exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Completers
Secondary outcome measures
Difference in Patient Health Questionnaire-9 (PHQ-9)
Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
Difference of General Anxiety Disorder-7 (GAD-7) score
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psychosocial intervention + Cardiac Rehab ServicesExperimental Treatment2 Interventions
Cognitive Behavioral Therapy + Cardiac Rehab
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,409 Total Patients Enrolled
22 Trials studying Prostate Cancer
3,956 Patients Enrolled for Prostate Cancer
Alice Fan, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 6 more months.I have prostate cancer and am on or considering hormone therapy.I do not have uncontrolled heart pain or recent heart attacks.I can use a heart rehab app on my phone or tablet.I can care for myself and am able to join a cardiac rehab program if needed.You are currently experiencing suicidal thoughts or have been hospitalized for a mental health condition.I am a man aged 18 or older.You identify yourself as Black and/or African American.
Research Study Groups:
This trial has the following groups:- Group 1: Psychosocial intervention + Cardiac Rehab Services
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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