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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (supportive counseling)
Virtual Cardiac Rehabilitation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Inclusion Criteria Part A (Mental Health)

  • Self-Identify as Black and/or African American
  • Diagnosed with prostate cancer (per medical history; pathology not required) on Day 1, or is currently, or was formerly, receiving androgen deprivation. 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.
  • Males >= age 18
  • Life expectancy of >6 months
  • 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 mask during all in-person sessions (when required).

Inclusion Criteria: Part B (Cardiac Services)

  • Have completed the 2-hour intake (as documented by clinical social worker) from Part A. * ECOG Performance Status of <= 2, or at the investigator's discretion, ability to participate in a cardiac rehab program.
  • Participant must be able and willing to follow the cardiac rehabilitation activities.
  • Participant must be able to use a cardiac rehabilitation app on their smartphone or tablet.

Exclusion Criteria: Part A (Mental Health Services)

  • Actively engaging in self harm, or currently on a 5150 or 5250.

Exclusion Criteria: 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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Psychosocial intervention + Cardiac Rehab Services

Arm Description

Cognitive Behavioral Therapy + Cardiac Rehab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2021
Last Updated
June 21, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05099679
Brief Title
Pilot Study for Black Men With Prostate Cancer: Optimization Of Mental and Heart Health, the BOOM-Heart Study
Official Title
A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial intervention + Cardiac Rehab Services
Arm Type
Other
Arm Description
Cognitive Behavioral Therapy + Cardiac Rehab
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (supportive counseling)
Intervention Description
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
Intervention Name(s)
Virtual Cardiac Rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of Completers
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difference in Patient Health Questionnaire-9 (PHQ-9)
Time Frame
12 weeks
Title
Difference of General Anxiety Disorder-7 (GAD-7) score
Time Frame
12 weeks
Title
Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
Time Frame
12 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-Identify as Black and/or African American
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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]): 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sneha Mohile
Phone
(650) 725-5459
Email
smohile@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Fan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sneha Mohile
Email
smohile@stanford.edu
First Name & Middle Initial & Last Name & Degree
Alice C Fan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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