Multicomponent Adherence Intervention for Breast Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Columbia University Medical Center, New York, NY
Breast Cancer
Multicomponent Adherence Intervention - BehavioralEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
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
Other trials for Breast Cancer
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
Safety Progress
Other trials for Breast Cancer
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: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
Closest Location: Columbia University Medical Center · New York, NY
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 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.
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Conditions
Cancer Related
Treatments