Multicomponent Adherence Intervention for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Columbia University Medical Center, New York, NY
Breast Cancer
Multicomponent Adherence Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Baseline

24 Weeks
Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
24 weeks
Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks
52 Weeks
Number of Participants Adherent to ET and CVD Medication at 52 Weeks
52 weeks
Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks
Baseline
Impact of events using the Impact of Events Scale (IES)
Baseline and 24 weeks
Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks
Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks
Baseline and 52 weeks
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks
Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks
Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks
Week 52
Change in Regimen Complexity
Baseline to 24 weeks
Change in blood pressure at 24 weeks
Baseline to 52 weeks
Change in blood pressure at 52 weeks
Change in low-density lipoprotein (LDL) cholesterol
at baseline
Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire

Trial Safety

Trial Design

1 Treatment Group

Adherence Intervention
1 of 1
Experimental Treatment

350 Total Participants · 1 Treatment Group

Primary Treatment: Multicomponent Adherence Intervention · No Placebo Group · N/A

Adherence Intervention
Behavioral
Experimental Group · 1 Intervention: Multicomponent Adherence Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
Closest Location: Columbia University Medical Center · New York, NY
Photo of columbia university medical center 1Photo of columbia university medical center 2Photo of columbia university medical center 3
2002First Recorded Clinical Trial
30 TrialsResearching Breast Cancer
932 CompletedClinical Trials

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,266 Previous Clinical Trials
1,573,466 Total Patients Enrolled
24 Trials studying Breast Cancer
37,099 Patients Enrolled for Breast Cancer
Dawn Hershman, MDPrincipal InvestigatorColumbia University
12 Previous Clinical Trials
1,368 Total Patients Enrolled
11 Trials studying Breast Cancer
1,318 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years.
You have been treated with an anti-HER2 therapy for at least 3 years.
You must be prescribed at least 1 antihypertensive or statin medication for CVD prevention.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.