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| ID | Type | Description | Link |
|---|---|---|---|
| PROS0109 | Other Identifier | Stanford | |
| NCI-2022-02832 | Other Identifier | Clinical Trials Reporting Program |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial intervention + Cardiac Rehab Services | Other | Cognitive Behavioral Therapy + Cardiac Rehab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (supportive counseling) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Patient Health Questionnaire-9 (PHQ-9) | 12 weeks | |
| Difference of General Anxiety Disorder-7 (GAD-7) score | 12 weeks | |
| Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score |
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Inclusion Criteria for Part A (Mental Health Services)
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)
Self-Identify as Black and/or African American
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| Name | Affiliation | Role |
|---|---|---|
| Alice C Fan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Virtual Cardiac Rehabilitation | Behavioral | 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 |
|
| 12 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |