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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University

About 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

visual or hearing impairment;

severe cognitive impairment;

severe mental illness interfering with ability to participate

Trial design

Treatments tested in this trial

  • Patient Navigation Program

Treatment groups

26 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Duke University

Lead sponsor

Pfizer

Collaborator