Clinical trial NCT05496829: IMPACT Trial: Intervention to iMProve AdherenCe Equitably
Official title: IMPACT Trial: Intervention to iMProve AdherenCe Equitably
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-08-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Primary outcomes:
measure: Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
timeFrame: 24 Weeks
Secondary outcomes:
measure: Number of Participants Adherent to ET and CVD Medication at 52 Weeks
timeFrame: 52 Weeks
measure: Change in blood pressure at 24 weeks
timeFrame: Baseline to 24 weeks
measure: Change in blood pressure at 52 weeks
timeFrame: Baseline to 52 weeks
measure: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: Baseline to 52 weeks
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks
timeFrame: Baseline and 52 weeks
measure: Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change in Regimen Complexity
timeFrame: Baseline and at 52 weeks
measure: Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire
timeFrame: at baseline
measure: Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks
timeFrame: 24 weeks
measure: Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks
timeFrame: 52 weeks
measure: Impact of events using the Impact of Events Scale (IES)
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References: