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Adherence Intervention for Breast Cancer Treatment Compliance

N/A

Recruiting

Led By Dawn Hershman, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial is testing whether or not a multi-component intervention can help people with early-stage breast cancer who are also taking cardiovascular disease medication to stick to their endocrine therapy.

Who is the study for?

The IMPACT Trial is for men and women over 18 with early-stage breast cancer who are on endocrine therapy and a CVD medication but have trouble sticking to their treatment. They must be within 3 years of completing initial treatments like surgery or chemo, speak English or Spanish, and see a doctor in the New York Presbyterian Health system.Check my eligibility

What is being tested?

This study tests if a special program helps people with breast cancer take their hormone therapy and heart meds better compared to usual care. It checks how well patients follow their prescriptions using questionnaires and pharmacy records at the six-month mark.See study design

What are the potential side effects?

Since this trial focuses on improving medication adherence rather than testing new drugs, side effects aren't the main concern. However, participants may experience stress or discomfort from additional monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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 Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks

Secondary outcome measures

Change in Regimen Complexity

Change in blood pressure at 24 weeks

Change in blood pressure at 52 weeks

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 Intervention

Usual Care from treating providers

Group II: Adherence InterventionExperimental Treatment1 Intervention

Multicomponent Adherence Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,432 Previous Clinical Trials

2,460,623 Total Patients Enrolled

28 Trials studying Breast Cancer

23,289 Patients Enrolled for Breast Cancer

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

383 Previous Clinical Trials

1,215,861 Total Patients Enrolled

4 Trials studying Breast Cancer

1,660 Patients Enrolled for Breast Cancer

Dawn Hershman, MDPrincipal InvestigatorColumbia University

13 Previous Clinical Trials

1,453 Total Patients Enrolled

12 Trials studying Breast Cancer

1,409 Patients Enrolled for Breast Cancer

Media Library

Multicomponent Adherence Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05496829 — N/A

Breast Cancer Research Study Groups: Adherence Intervention, Usual Care

Breast Cancer Clinical Trial 2023: Multicomponent Adherence Intervention Highlights & Side Effects. Trial Name: NCT05496829 — N/A

Multicomponent Adherence Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496829 — N/A

Frequently Asked Questions

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

How many people are engaged in this experimentation?

"Affirmative. The information found on clinicaltrials.gov confirms that recruitment for this study is ongoing, with an initial posting date of August 31st 2021 and a last update of August 9th 2022. 350 participants are sought from 1 location to complete the trial."

Answered by AI

Does this trial accept any individuals aged 25 or older?

"This medical trial is only open to those aged 18-99. Those younger than 18 have access to 52 different clinical trials, while elderly patients (over 65) can choose from 1,335 studies."

Answered by AI

Are participants being accepted into the experiment at this time?

"Indeed, this trial is currently enlisting volunteers. According to clinicaltrials.gov, the research was initiated on August 31st 2021 and most recently updated on August 9th 2022."

Answered by AI

Under what criteria can individuals partake in this experiment?

"This scientific research is recruiting 350 individuals with breast cancer, ranging from 18 to 99 years old. To be eligible for the study, patients must meet specific conditions: age of majority or above; stage I-III diagnosis of malignancy necessitating endocrine treatment; completion within three years of surgical/chemotherapeutic intervention (excluding targeted HER2 therapy); self-reported nonadherence towards ET and CVD medication according to DOSE questionnaire; a prescription for at least one antihypertensive drug or statin medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Dawn L. Hershman 2023. "IMPACT Trial: Intervention to iMProve AdherenCe Equitably". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496829.