Adherence Intervention in Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121453
• Other study ID #: AAAU9129
• Secondary ID: P50MD017341
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: December 10, 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Research Nurse Navigator
• Phone: 212-342-5162
• Email: cancerclinicaltrials[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine therapy (ET), CDK4/6 inhibitor (CDK 4/6i), and CVD medications. To assess the acceptability and appropriateness of this intervention in patients with MBC and CVD risk factors through validated measures of implementation outcomes. To gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of study participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 10, 2026
• Est. primary completion date: November 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Women or men age >18 years
• Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a CDK4/6i
• Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment
• Self-report of at least some nonadherence ET/CDK4/6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4/6i, and/or CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days <80%).

Exclusion Criteria:

• Non-English or Non-Spanish speaking
• Not cognitively able to complete study requirements
• Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)
• Unavailable for 28 weeks of follow-up

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Multicomponent Adherence Intervention
multi-part intervention to reduce barriers to medication use

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants on multicomponent adherence intervention	To determine the preliminary efficacy of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer with at least some nonadherence to endocrine therapy, CDK4/6 inhibitor, and/or at least one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication), based on its impact on concurrent adherence to endocrine therapy, CDK4/6 inhibitor, and to CVD medication at 28 weeks (or at time of progression of MBC, if prior to 28-week timepoint), assessed by a combination of self-report using the Voils DOSE Nonadherence measure and pharmacy fill data using pharmacy dispensing records available in the Electronic Health Record (EHR).	at 28 weeks
Secondary	Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks	Healthcare related quality of life (HRQOL), measured by the Patient-Reported Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) measuring health-related quality of life. Raw scores (range 1-5 for each question) are translated into T-scores for each domain (physical function, depression, pain intensity, etc) so that the values follow a normal distribution with a population mean T-score of 50 and a standard deviation of 10. Higher scores can mean better or worse outcomes depending on the domain reported.; Outcomes Measurement Information System (PROMIS)-29.	at 28 weeks
Secondary	Digital Health Literacy Scale	A measure of the basic skills necessary for using digital health services, as assessed by a 3-item questionnaire (questions from the Health Information National Trend Survey (HINTS). Scores range with a higher score indicating better level of literacy.(Health Information National Trend Survey). To score the 3-item digital health care literacy scale, we used a sum score of all the items (range 0-4 for each item, sum score range 0-12) such that higher scores indicated higher digital health care literacy.	at 28 weeks
Secondary	Number in using the Voils DOSE Nonadherence measure	Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications).	at 28 weeks
Secondary	Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks	Self-efficacy with medication regimen, as measured by the Medical Adherence Self- Efficacy Scale (MASES-R). The Medication Adherence Self-Efficacy Scale (MASES). Each question from the 12-item measure is score from 1-4, and the total score for this scale is calculated as the average score of all the items, such that the minimal total score is 1 and the maximal total score is 4. Higher scores indicate higher medication adherence self-efficacy.	at 28 weeks
Secondary	total number of medications and number of doses per day	Medications and regimen complexity	at 28 weeks