IMPACT Trial: Intervention to iMProve AdherenCe Equitably

May 4, 2026 updated by: Dawn L. Hershman, Columbia University
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Dawn Hershman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adherence Intervention
Multicomponent Adherence Intervention
Behavioral: Multicomponent Adherence Intervention
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.
Other: Usual Care
Usual Care from treating providers
Other: Usual Care
Receipt of usual care from providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
Time Frame: 24 Weeks
Adherence to ET and CVD medication is a composite of both medication refills at 24 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report.
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Adherent to ET and CVD Medication at 52 Weeks
Time Frame: 52 Weeks
Adherence to ET and CVD medication is a composite of both medication refills at 52 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report.
52 Weeks
Change in blood pressure at 24 weeks
Time Frame: Baseline to 24 weeks
To compare office blood pressure changes from baseline to 24 weeks
Baseline to 24 weeks
Change in blood pressure at 52 weeks
Time Frame: Baseline to 52 weeks
To compare office blood pressure changes from baseline to 52 weeks
Baseline to 52 weeks
Change in low-density lipoprotein (LDL) cholesterol
Time Frame: Baseline to 52 weeks
To compare changes in low-density lipoprotein (LDL) cholesterol from baseline to 52 weeks.
Baseline to 52 weeks
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks
Time Frame: Baseline and 24 weeks
To evaluate changes in healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at baseline and 24 weeks. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29 is a well-validated assessment tool that includes 29 questions evaluating 7 domains including physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference (which is often associated with ET adherence). Several of these measures have been important determinants of medication adherence and have the potential to moderate intervention effects.
Baseline and 24 weeks
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks
Time Frame: Baseline and 52 weeks
To evaluate changes in healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at baseline and 52 weeks. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29 is a well-validated assessment tool that includes 29 questions evaluating 7 domains including physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference (which is often associated with ET adherence). Several of these measures have been important determinants of medication adherence and have the potential to moderate intervention effects.
Baseline and 52 weeks
Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks
Time Frame: Baseline and 24 weeks
To compare participants' satisfaction with their medication regimens as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess participants' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction.
Baseline and 24 weeks
Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks
Time Frame: Baseline and 52 weeks
To compare participants' satisfaction with their medication regimens, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess participants' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction.
Baseline and 52 weeks
Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks
Time Frame: Baseline and 24 weeks
To compare participants' self-efficacy with their medication regimens as measured by the Medical Adherence Self-Efficacy Scale (MASES) at baseline and 24 weeks. MASES is a 13-item form, 12 of the items ask about confidence in ability to make medication adherence part of daily routine. The total scale ranges from 1-4, and it is an average score of all 13 items.
Baseline and 24 weeks
Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks
Time Frame: Baseline and 52 weeks
To compare participants' self-efficacy with their medication regimens as measured by the Medical Adherence Self-Efficacy Scale (MASES) at baseline and 52 weeks. MASES is a 13-item form, 12 of the items ask about confidence in ability to make medication adherence part of daily routine. The total scale ranges from 1-4, and it is an average score of all 13 items.
Baseline and 52 weeks
Change in Regimen Complexity
Time Frame: Baseline and at 52 weeks
To evaluate regimen complexity at baseline and at 52 weeks. This will be extracted through manual chart review from the EHR. The investigators will extract total number of prescription medications and frequency of dosing for CVD medications as ET is once daily.
Baseline and at 52 weeks
Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire
Time Frame: at baseline
To evaluate reasons for medication nonadherence at baseline using the DOSE-Nonadherence reasons for nonadherence questionnaire
at baseline
Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks
Time Frame: 24 weeks
To evaluate reasons for medication nonadherence at 24 weeks using the DOSE-Nonadherence reasons for nonadherence questionnaire. The DOSE-Nonadherence Reasons for Nonadherence questionnaire asks how much 21 reasons for nonadherence contribute to missing doses such as trouble affording medications, insufficient social support, complexity of regimen, and concerns about adverse effects. This will be used to assess the effect of the intervention on barriers to adherence.
24 weeks
Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks
Time Frame: 52 weeks
To evaluate reasons for medication nonadherence at 52 weeks using the DOSE-Nonadherence reasons for nonadherence questionnaire. The DOSE-Nonadherence Reasons for Nonadherence questionnaire asks how much 21 reasons for nonadherence contribute to missing doses such as trouble affording medications, insufficient social support, complexity of regimen, and concerns about adverse effects. This will be used to assess the effect of the intervention on barriers to adherence.
52 weeks
Impact of events using the Impact of Events Scale (IES)
Time Frame: Baseline
To evaluate the impact of events using the Impact of Events Scale (IES) to evaluate intrusive and avoidant thoughts about participant's underlying breast cancer diagnosis at baseline. IES is a 15-item scale which queries intrusive and avoidant thoughts about a distressing event (breast cancer) in the past 7 days (similar to post-traumatic stress disorder [PTSD] symptoms). Each item has a scoring range of 0 (not at all)-5(often). This scale has been associated with disparities in ET and CVD medication nonadherence
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Dawn Hershman, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT8817
  • 1P50MD017341 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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