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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06983691

Registry updated: 2026-09-08
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Description

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.

Interventions

  • Patient Navigation Program (Behavioral)
    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.

Eligibility criteria

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

Conditions

HER2+ Metastatic Breast Cancer (MBC)

Locations

  • Duke Cancer Institute — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record