Adherence Intervention in Patients With Metastatic Breast Cancer

NCT06121453 | Suspended DMC

• 2 other identifiers: AAAU9129P50MD017341
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants on multicomponent adherence intervention

  To determine the preliminary efficacy of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer with at least some nonadherence to endocrine therapy, CDK4/6 inhibitor, and/or at least one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication), based on its impact on concurrent adherence to endocrine therapy, CDK4/6 inhibitor, and to CVD medication at 28 weeks (or at time of progression of MBC, if prior to 28-week timepoint), assessed by a combination of self-report using the Voils DOSE Nonadherence measure and pharmacy fill data using pharmacy dispensing records available in the Electronic Health Record (EHR).

  at 28 weeks

Secondary Outcomes (5)

• Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks

  at 28 weeks

• Digital Health Literacy Scale

  at 28 weeks

• Number in using the Voils DOSE Nonadherence measure

  at 28 weeks

• Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks

  at 28 weeks

• total number of medications and number of doses per day

  at 28 weeks

Study Arms (1)

Single Arm: Adherence Intervention

EXPERIMENTAL

Multicomponent Adherence Intervention

Behavioral: Multicomponent Adherence Intervention

Interventions

Multicomponent Adherence Intervention BEHAVIORAL

multi-part intervention to reduce barriers to medication use

Single Arm: Adherence Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)