26 Participants NeededMy employer runs this trial

Patient Navigation for Breast Cancer

SD
MW
Overseen ByMichael W Willis
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to test a novel nurse-delivered patient navigation program for women with HER2+ metastatic breast cancer (mBC) receiving tucatinib, trastuzumab, and capecitabine. The program will focus on enhancing understanding of the treatment regimen, managing symptoms and adherence, and improving coping and self-management skills. If successful, the program could be integrated into clinical care to better support mBC patients. The main question the study aims to answer is: is the patient navigation program feasible and acceptable for mBC patients?

Participants will receive patient navigation sessions over about 6 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3 and 6 weeks after enrollment, with the last assessment occurring after completion of the patient navigation program sessions. Participants will also complete a post-program exit interview.

Who Is on the Research Team?

RS

Rebecca Shelby, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for women diagnosed with HER2-positive metastatic breast cancer who can speak and read English and are currently being treated with tucatinib, trastuzumab, and capecitabine.

Inclusion Criteria

I was assigned female at birth.
able to speak and read English
I have been diagnosed with HER2-positive metastatic breast cancer.
See 2 more

Exclusion Criteria

visual or hearing impairment
severe cognitive impairment
I do not have a severe mental illness that prevents me from participating.

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Navigation Program

Trial Overview

The study is testing a nurse-led patient navigation program designed to help patients better understand their treatment, manage symptoms, stick to their medication schedule, and cope emotionally. The program lasts about 6 weeks alongside regular care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patient Navigation ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

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Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University