NCT05496829 IMPACT Trial: Intervention to iMProve AdherenCe Equitably
| NCT ID | NCT05496829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2023-03-02 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Dawn Hershman, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05496829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05496829 currently recruiting?
Yes, NCT05496829 is actively recruiting participants. Contact the research team at cancerclinicaltrials@cumc.columbia.edu for enrollment information.
Where is the NCT05496829 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05496829 clinical trial?
NCT05496829 is sponsored by Columbia University. The principal investigator is Dawn Hershman, MD at Columbia University. The trial plans to enroll 350 participants.
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