Adherence Intervention in Patients With Metastatic Breast Cancer

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Columbia University

Status

Enrolling

Conditions

Breast Cancer

Treatments

Behavioral: Multicomponent Adherence Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06121453
P50MD017341 (U.S. NIH Grant/Contract)
AAAU9129

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Single Arm: Adherence Intervention
Experimental group
Description:
Multicomponent Adherence Intervention
Treatment:
Behavioral: Multicomponent Adherence Intervention

Trial contacts and locations

1

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Central trial contact

Research Nurse Navigator; Claire Sathe, MD

Data sourced from clinicaltrials.gov

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