Prostate CancerNCT05099679
Pilot Study for Black Men With Prostate Cancer: Optimization Of Mental and Heart Health, the BOOM-Heart Study
A study testing Cognitive behavioral therapy (supportive counseling) and Virtual Cardiac Rehabilitation in people with Prostate Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cognitive behavioral therapy (supportive counseling) and Virtual Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Actively engaging in self harm, or currently on a 5150 or 5250.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
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.
Read the 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
- Prostate Cancer
- Being tested
- Cognitive behavioral therapy (supportive counseling), Virtual Cardiac Rehabilitation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (supportive counseling)Behavioural
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
Virtual Cardiac RehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial intervention + Cardiac Rehab Services | Other | Cognitive Behavioral Therapy + Cardiac Rehab Receives: Behavioral: Cognitive behavioral therapy (supportive counseling); Behavioral: Virtual Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
Difference in Patient Health Questionnaire-9 (PHQ-9)
Measured: 12 weeks
Difference of General Anxiety Disorder-7 (GAD-7) score
Measured: 12 weeks
Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start18 Nov 2021
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Fan, Stanford University
- Investigators
- Alice C Fan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099679
- Sponsor's protocol ID
- IRB-60375
- Other IDs
- PROS0109, NCI-2022-02832
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05099679
- Acronym / sponsor ID
- IRB-60375
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial intervention + Cardiac Rehab Services | Other | Behavioral: Cognitive behavioral therapy (supportive counseling), Behavioral: Virtual Cardiac RehabilitationCognitive Behavioral Therapy + Cardiac Rehab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (3 listed)
- Actively engaging in self harm, or currently on a 5150 or 5250.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy (supportive counseling)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 | Behavioural | Psychosocial intervention + Cardiac Rehab Services |
| Virtual Cardiac RehabilitationIf 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 | Behavioural | Psychosocial intervention + Cardiac Rehab Services |
Primary outcome
Proportion of Completers
Time frame: 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.
3 secondary outcomes
Difference in Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 weeks
Difference of General Anxiety Disorder-7 (GAD-7) score
Time frame: 12 weeks
Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice C Fan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (supportive counseling) and Virtual Cardiac Rehabilitation in people with Prostate Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Completers (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.