To hear about similar clinical trials, please enter your email below
Trial Title:
Adherence Intervention in Patients With Metastatic Breast Cancer
NCT ID:
NCT06121453
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multicomponent Adherence Intervention
Description:
multi-part intervention to reduce barriers to medication use
Arm group label:
Single Arm: Adherence Intervention
Summary:
To evaluate the preliminary efficacy of a multicomponent adherence intervention focused
on enhancing digital equity and pharmaco-equity among nonadherent patients with
metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine
therapy (ET), CDK4/6 inhibitor (CDK 4/6i), and CVD medications. To assess the
acceptability and appropriateness of this intervention in patients with MBC and CVD risk
factors through validated measures of implementation outcomes. To gain a deeper
understanding of the impact of social determinants of health (SDOH) on medication
nonadherence through semi-structured interviews with a subset of study participants.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women or men age >18 years
- Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a
CDK4/6i
- Prescribed at least 1 antihypertensive or statin medication for CVD prevention or
treatment
- Self-report of at least some nonadherence ET/CDK4/6i or CVD medication on
nonadherence screener or verbally to a treating clinician, or nonadherent to ET,
CDK4/6i, and/or CVD medication on pharmacy fill data in the EHR (proportion of days
covered over prior 180 days <80%).
Exclusion Criteria:
- Non-English or Non-Spanish speaking
- Not cognitively able to complete study requirements
- Inability to provide informed consent for any other reason (e.g, severe psychiatric
illness, active substance use)
- Unavailable for 28 weeks of follow-up
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claire Sathe, MD
Phone:
212-305-8923
Email:
ds1099@cumc.columbia.edu
Start date:
April 12, 2024
Completion date:
December 10, 2026
Lead sponsor:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
National Institute on Minority Health and Health Disparities (NIMHD)
Agency class:
NIH
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06121453
