Intervention to improve medication adherence in breast cancer patients
Official title: IMPACT Trial: Intervention to iMProve AdherenCe Equitably
Run by Columbia University · NCT05496829 · Data updated 2026-11-12
This study is testing a new program to help women with early-stage breast cancer stick to their medications for both cancer and heart health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 2, 2023 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT05496829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years diagnosed with stage I-III breast cancer who are currently prescribed endocrine therapy and at least one cardiovascular medication.
✕Probably not a fit
Patients who have experienced breast cancer recurrence or those who are not able to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate the effectiveness of a multicomponent adherence intervention designed for individuals with early-stage breast cancer who are also taking cardiovascular disease medications. Participants will be assessed for their adherence to both endocrine therapy and cardiovascular medications over a 24-week period using self-reported questionnaires and pharmacy fill data from electronic health records. The study seeks to identify whether this intervention can enhance medication adherence among this patient population.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence, leading to better health outcomes for patients with breast cancer and cardiovascular conditions.
How similar studies have gone: Other studies have shown promise in improving medication adherence through similar multicomponent interventions, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Columbia University Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Dawn Hershman, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.