Clinical trial · Interventional
IMPACT Trial: Intervention to iMProve AdherenCe Equitably
NCT05496829CI-TRIAL-00110597recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multicomponent Adherence Intervention | Behavioral | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adherence Intervention
- description
- Multicomponent Adherence Intervention
- interventionNames
- Behavioral: Multicomponent Adherence Intervention
- type
- OTHER
- label
- Usual Care
- description
- Usual Care from treating providers
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
- timeFrame
- 24 Weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSathe 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 40653311