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RecruitingInterventional

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

NCT ID: NCT05496829Sponsor: Columbia UniversityLast updated: 2026-05-06

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).

Arms & interventions

  • BehavioralMulticomponent Adherence Intervention

    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.

  • OtherUsual Care

    Receipt of usual care from providers

Outcome measures

Primary

  • 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.

    Time frame: 24 Weeks

Secondary

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

    Time frame: 52 Weeks

  • Change in blood pressure at 24 weeks

    Time frame: Baseline to 24 weeks

  • Change in blood pressure at 52 weeks

    Time frame: Baseline to 52 weeks

  • Change in low-density lipoprotein (LDL) cholesterol

    Time frame: Baseline to 52 weeks

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

    Time frame: Baseline and 24 weeks

  • Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks

    Time frame: Baseline and 52 weeks

  • Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks

    Time frame: Baseline and 24 weeks

  • Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks

    Time frame: Baseline and 52 weeks

  • Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks

    Time frame: Baseline and 24 weeks

  • Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks

    Time frame: Baseline and 52 weeks

  • Change in Regimen Complexity

    Time frame: Baseline and at 52 weeks

  • Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire

    Time frame: at baseline

  • Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks

    Time frame: 24 weeks

  • Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks

    Time frame: 52 weeks

  • Impact of events using the Impact of Events Scale (IES)

    Time frame: Baseline

Eligibility criteria

Sex: AllAge: 18 Years to 99 YearsHealthy volunteers: No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations (1)

Columbia University Medical Center

New York, New York, 10032

Recruiting
Dawn Hershman, MD · Contact
212-305-1945dlh23@columbia.edu
Dawn Hershman, MD · Principal Investigator

References

  • 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.(PubMed)