Adherence Intervention in Patients With Metastatic Breast Cancer

NCT ID: NCT06121453

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-12

Study Completion Date

2026-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single Arm: Adherence Intervention

Multicomponent Adherence Intervention

Group Type EXPERIMENTAL

Multicomponent Adherence Intervention

Intervention Type BEHAVIORAL

multi-part intervention to reduce barriers to medication use

Interventions

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Multicomponent Adherence Intervention

multi-part intervention to reduce barriers to medication use

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Claire Sathe, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P50MD017341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU9129

Identifier Type: -

Identifier Source: org_study_id

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