Recruiting

Adherence Intervention

Sponsor:

Columbia University

Code:

NCT06121453

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Multicomponent Adherence Intervention

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT06121453

Start date

Apr 12, 2024

Status verified date

Jul, 2026

Completion date

Dec 10, 2026

Anticipated

Primary completion date

Nov 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Single Arm: Adherence Intervention

Multicomponent Adherence Intervention

Interventions

Multicomponent Adherence Intervention

multi-part intervention to reduce barriers to medication use

Primary outcome measure

  • Number of Participants on multicomponent adherence intervention [ Time Frame: at 28 weeks ]

Central Contacts and Locations

Central contacts

Research Nurse Navigator

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Claire Sathe, MD

212-305-8923ds1099@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Claire Sathe, MD

212-305-8923ds1099@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-07-28.