CV CARE: CardioVascular Care in PC Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06202820
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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)

Key Dates

Start date
Jan 18, 2024
Status verified
Aug 2025
Primary completion
Jun 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: CV Care Program
    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.
  • Experimental: CV Care Program 2
    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.

Primary Outcome Measure

Participant Retention Rate in CV CARE 2 [ Time Frame: Weeks 4 and 24 in CV CARE 2 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Alicia Morgans, MD, MPH
[email protected]
857-215-1605
Alicia Morgans, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Alicia Morgans, MD, MPH
[email protected]
857-215-1605
Alicia Morgans, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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