NCT06983691

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

Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HER2+ Metastatic Breast Cancer (MBC)

Interventions

Type	Name	Description
BEHAVIORAL	Patient Navigation Program	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-21
• Last updated: 2026-03-06