IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05496829
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Multicomponent Adherence Intervention — BEHAVIORAL
    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.
  • Usual Care — OTHER
    Receipt of usual care from providers

Study Details

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).

Key Dates

Start date
Mar 2, 2023
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Adherence Intervention
    Multicomponent Adherence Intervention
  • Other: Usual Care
    Usual Care from treating providers

Primary Outcome Measure

Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks [ Time Frame: 24 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Dawn Hershman, MD
[email protected]
212-305-1945
Dawn Hershman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
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By specialty
OncologyBreast oncologyWomen's health
By research site
Columbia University Medical Center· New York, NY

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