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Adherence Program for Metastatic Breast Cancer

Q: How many subjects are currently partaking in this research project?

Affirmative, clinicaltrials.gov displays that this medical trial is still recruiting for patients. This study was first posted on November 1st 2023 and updated most recently on the 6th of the same month. The investigators need to find 35 applicants at a single site.

Q: For whom is enrollment in this clinical trial an appropriate option?

This clinical trial is seeking 35 participants that, between them, meet the criteria of being aged 18-99 and having a diagnosis of <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>.

Q: Is the eligibility for this clinical trial confined to persons aged 50 years or younger?

Eligibility for this trial is restricted to those aged 18 and 99. There are 72 trials that cater exclusively to minors, while the elderly (over 65) have access to 2661 specialised studies.

Q: Is recruitment of test participants still open for this experiment?

Affirmative. Evidenced by the data on clinicaltrials.gov, this trial is currently searching for participants. It was posted to the website on November 1st 2023 and has since been updated on November 6th 2023. Currently seeking 35 volunteers from a single clinic site.

N/A

Recruiting

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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%)

Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a CDK4/6i

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 28 weeks

Awards & highlights

Study Summary

This trial evaluates the effectiveness of a program to help people with metastatic breast cancer & CVD risk factors to take their medication & account for SDOH.

Who is the study for?

This trial is for men and women over 18 with stage IV/metastatic breast cancer who are on endocrine therapy and a CDK4/6 inhibitor, plus medication for cardiovascular disease risk. Participants must have shown some nonadherence to their medication regimen but be able to consent and follow the study requirements in English or Spanish.Check my eligibility

What is being tested?

The trial tests a multicomponent adherence intervention aimed at improving how patients with metastatic breast cancer manage their medications, especially those also at risk of cardiovascular disease. It will evaluate effectiveness, acceptability, and the influence of social factors on sticking to prescribed treatments.See study design

What are the potential side effects?

Since this is an adherence-focused intervention rather than a drug trial, traditional side effects aren't applicable. However, participants may experience stress or discomfort related to increased attention to medication routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not always taken my cancer or heart disease medication as prescribed.

Select...

I have stage IV breast cancer and am on hormone therapy and CDK4/6 inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants on multicomponent adherence intervention

Secondary outcome measures

Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks

Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks

Digital Health Literacy Scale

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm: Adherence InterventionExperimental Treatment1 Intervention

Multicomponent Adherence Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,324 Total Patients Enrolled

4 Trials studying Breast Cancer

1,975 Patients Enrolled for Breast Cancer

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,224 Total Patients Enrolled

28 Trials studying Breast Cancer

23,604 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are currently partaking in this research project?

"Affirmative, clinicaltrials.gov displays that this medical trial is still recruiting for patients. This study was first posted on November 1st 2023 and updated most recently on the 6th of the same month. The investigators need to find 35 applicants at a single site."

Answered by AI

For whom is enrollment in this clinical trial an appropriate option?

"This clinical trial is seeking 35 participants that, between them, meet the criteria of being aged 18-99 and having a diagnosis of breast cancer."

Answered by AI

Is the eligibility for this clinical trial confined to persons aged 50 years or younger?

"Eligibility for this trial is restricted to those aged 18 and 99. There are 72 trials that cater exclusively to minors, while the elderly (over 65) have access to 2661 specialised studies."

Answered by AI

Is recruitment of test participants still open for this experiment?

"Affirmative. Evidenced by the data on clinicaltrials.gov, this trial is currently searching for participants. It was posted to the website on November 1st 2023 and has since been updated on November 6th 2023. Currently seeking 35 volunteers from a single clinic site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adherence Intervention in Patients With Metastatic Breast Cancer

Claire Sathe, MD 2024. "Adherence Intervention in Patients With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121453.