Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib

Duke University

Status: Not yet enrolling

Conditions: HER2+ Metastatic Breast Cancer (MBC)

Treatments: Behavioral: Patient Navigation Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06983691

Pro00117920

Details and patient eligibility

About

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 12 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3, 6, 9, and 12 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.

Enrollment: 26 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female (sex assigned at birth);
• ≥18 years of age at enrollment;
• diagnosed with HER2+ metastatic breast cancer (mBC);
• receiving treatment with tucatinib combined with capecitabine and trastuzumab;
• able to speak and read English

Exclusion criteria

• visual or hearing impairment;
• severe cognitive impairment;
• severe mental illness interfering with ability to participate

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Patient Navigation Program

Experimental group

Description:

The patient navigation program will integrate 1) education to enhance understanding of the treatment regimen, follow-up care, and the importance of adherence, 2) symptom management and adherence strategies, and 3) skills and resources to enhance women's symptom coping and self-management abilities.

Treatment:

Behavioral: Patient Navigation Program