CV CARE: CardioVascular Care in PC Patients | NCT06202820

NCT06202820

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
National Comprehensive Cancer Network	NETWORK

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CV Care Program	Experimental	Study procedures will be conducted as follows: Standard of care androgen deprivation therapy. 4 week standard-of-care follow up visit in clinic with CV care education module completion. 12-week standard-of-care prostate cancer care visit with oncologist. 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members. The CV Care program will be revised through participant feedback from assessments, surveys, focus groups, and exit-interviews. The revised CV Care Program will be used in the next cohort.	Behavioral: CV Care Program
CV Care Program 2	Experimental	Study procedures will be conducted as follows: Standard of care androgen deprivation therapy. 4 week standard-of-care follow up visit in clinic with CV care education module completion. 12-week standard-of-care prostate cancer care visit with oncologist. 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members. Participant feedback from surveys, exit-interviews, and possibly focus groups will be collected.	Behavioral: CV Care Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CV Care Program	Behavioral	Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Retention Rate in CV CARE 2	The percentage of a continued participation rate at week 24 of participants who participate at week 4 in the revised iteration of the program (CV CARE 2).	Weeks 4 and 24 in CV CARE 2

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants on Statin Medications in CV CARE	The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.
Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.
Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.
Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.
Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.
Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.
Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.
Age ≥18 years.
Life expectancy of greater than 6 months.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.
Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.
Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.
Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.

Name	Role	Phone	Extension	Email
Alicia Morgans, MD, MPH	Contact	857-215-1605		aliciak_morgans@dfci.harvard.edu

Name	Affiliation	Role
Alicia Morgans, MD, MPH	Dana-Farber Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital	Recruiting	Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

ID	Term
D011471	Prostatic Neoplasms
D002318	Cardiovascular Diseases