## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** IRB-60375
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
#### Secondary ID Infos
**Domain:** Stanford
**ID:** PROS0109
**Type:** OTHER
**Domain:** Clinical Trials Reporting Program
**ID:** NCI-2022-02832
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-10

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-11-18

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2021-10-29
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-11
**Study First Submit QC Date:** 2021-10-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Stanford University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Prostate Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cognitive Behavioral Therapy + Cardiac Rehab

**Intervention Names:**

- Behavioral: Cognitive behavioral therapy (supportive counseling)

- Behavioral: Virtual Cardiac Rehabilitation

**Label:** Psychosocial intervention + Cardiac Rehab Services

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Psychosocial intervention + Cardiac Rehab Services

**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

**Name:** Cognitive behavioral therapy (supportive counseling)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Psychosocial intervention + Cardiac Rehab Services

**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

**Name:** Virtual Cardiac Rehabilitation

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Proportion of Completers

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Measure:** Difference in Patient Health Questionnaire-9 (PHQ-9)

**Time Frame:** 12 weeks

**Measure:** Difference of General Anxiety Disorder-7 (GAD-7) score

**Time Frame:** 12 weeks

**Measure:** Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score

**Time Frame:** 12 weeks

### Eligibility Module

**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 \[b\]):

  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.

**Gender Based:** True

**Gender Description:** Self-Identify as Black and/or African American

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** smohile@stanford.edu

**Name:** Sneha Mohile

**Phone:** (650) 725-5459

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Palo Alto

**Contacts:**

***Contact 1:***

- **Email:** smohile@stanford.edu

- **Name:** Sneha Mohile

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alice C Fan, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Stanford University

**State:** California

**Status:** RECRUITING

**Zip:** 94305

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Alice Fan, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
