Adherence Intervention in Patients With Metastatic Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06121453
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Multicomponent Adherence Intervention — BEHAVIORAL
    multi-part intervention to reduce barriers to medication use

Study Details

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.

Key Dates

First listed
Nov 8, 2023
Start date
Apr 12, 2024
Status verified
Jul 2026
Primary completion
Nov 10, 2026
Completion
Dec 10, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Single Arm: Adherence Intervention
    Multicomponent Adherence Intervention

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Claire Sathe, MD
[email protected]
212-305-8923

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Breast cancer
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OncologyBreast oncologyWomen's health
By research site
Columbia University Medical Center· New York, NY

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