About this trial

This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.

The name of the intervention used in this research study is:

CV Care (cardiovascular risk assessment and management program)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: CV Care ProgramExperimental treatment 1 intervention

Group B: CV Care Program 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame

Weeks 4 and 24 in CV CARE 2

Secondary outcomes

1

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.

Time frame

5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

2

Proportion of Participants on Statin Medications in CV CARE 2

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.

Time frame

5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

3

Proportion of Participants on Blood Pressure Medications in CV CARE

The percentage of participants who initiate or adjust blood pressure 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.

Time frame

5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

4

Proportion of Participants on Blood Pressure Medications in CV CARE 2

The percentage of participants who initiate or adjust blood pressure 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.

Time frame

5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

CV CARE: CardioVascular Care in PC Patients

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts