To hear about similar clinical trials, please enter your email below
Trial Title:
IMPACT Trial: Intervention to iMProve AdherenCe Equitably
NCT ID:
NCT05496829
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multicomponent Adherence Intervention
Description:
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.
Arm group label:
Adherence Intervention
Intervention type:
Other
Intervention name:
Usual Care
Description:
Receipt of usual care from providers
Arm group label:
Usual Care
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dawn Hershman, MD
Phone:
212-305-1945
Email:
dlh23@columbia.edu
Investigator:
Last name:
Dawn Hershman, MD
Email:
Principal Investigator
Start date:
March 2, 2023
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
National Institute on Minority Health and Health Disparities (NIMHD)
Agency class:
NIH
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05496829
