RECRUITING

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Quick Facts

Study Start:2023-03-02
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05496829

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women or men age \>18 years
  2. * Diagnosed with stage I-III breast cancer prescribed endocrine therapy
  3. * 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)
  4. * Patients must be prescribed at least 1 antihypertensive or statin medication for CVD prevention
  5. * Self-report of at least some nonadherence ET or CVD medication on DOSE-Nonadherence Extent of Nonadherence questionnaire
  1. * Evidence of breast cancer recurrence
  2. * Non-English or Non-Spanish speaking
  3. * Not cognitively able to complete study requirements
  4. * Do not follow with either a primary care provider or cardiologist within the New York Presbyterian Health system's Epic EHR
  5. * Inability to provide informed consent

Contacts and Locations

Study Contact

Research Nurse Navigator
CONTACT
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Dawn Hershman, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Dawn Hershman, MD, PRINCIPAL_INVESTIGATOR, Columbia University

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 Registration Dates

Study Start Date2023-03-02
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-03-02
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer