NCT05496829

Brief Summary

To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
23mo left

Started Mar 2023

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2023Mar 2028

First Submitted

Initial submission to the registry

June 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 2, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4.1 years

First QC Date

June 17, 2022

Last Update Submit

May 4, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks

    Adherence to ET and CVD medication is a composite of both medication refills at 24 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report.

    24 Weeks

Secondary Outcomes (15)

  • Number of Participants Adherent to ET and CVD Medication at 52 Weeks

    52 Weeks

  • Change in blood pressure at 24 weeks

    Baseline to 24 weeks

  • Change in blood pressure at 52 weeks

    Baseline to 52 weeks

  • Change in low-density lipoprotein (LDL) cholesterol

    Baseline to 52 weeks

  • Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks

    Baseline and 24 weeks

  • +10 more secondary outcomes

Study Arms (2)

Adherence Intervention

EXPERIMENTAL

Multicomponent Adherence Intervention

Behavioral: Multicomponent Adherence Intervention

Usual Care

OTHER

Usual Care from treating providers

Other: Usual Care

Interventions

Multicomponent Adherence InterventionBEHAVIORAL

The adherence intervention will be comprised of a participant preference approach in which all participants undergo a baseline pharmacist-led medication optimization session and are offered training in how to use the patient portal and freely-available smartphone reminder app.

Adherence Intervention
Usual CareOTHER

Receipt of usual care from providers

Usual Care

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women or men age \>18 years
  • Diagnosed with stage I-III breast cancer prescribed endocrine therapy
  • Within 3-years of the end of early active treatment (e.g., surgery, chemotherapy not including human epidermal growth factor receptor 2 (HER2)-directed therapy, radiation)
  • Patients must be prescribed at least 1 antihypertensive or statin medication for CVD prevention
  • Self-report of at least some nonadherence ET or CVD medication on DOSE-Nonadherence Extent of Nonadherence questionnaire

You may not qualify if:

  • Evidence of breast cancer recurrence
  • Non-English or Non-Spanish speaking
  • Not cognitively able to complete study requirements
  • Do not follow with either a primary care provider or cardiologist within the New York Presbyterian Health system's Epic EHR
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

  • Sathe C, DeStephano D, Lee S, West H, Beauchemin M, Accordino M, Liyanage-Don N, Crew KD, Kukafka R, Harden E, Hershman DL, Kronish IM. Rationale and design of the IMProving Adherence to medications for breast Cancer and cardiovascular disease equiTably (IMPACT) randomized clinical trial. Contemp Clin Trials. 2025 Sep;156:108009. doi: 10.1016/j.cct.2025.108009. Epub 2025 Jul 11.

    PMID: 40653311DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dawn Hershman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Division of Hematology/Oncology

Study Record Dates

First Submitted

June 17, 2022

First Posted

August 11, 2022

Study Start

March 2, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

US(1)