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

Not Applicable

Not yet recruiting

• Conditions: HER2+ Metastatic Breast Cancer (MBC)

• Registration Number: NCT06983691
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2026-01
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants enrolled	9 months	Feasibility will be assessed by examining pilot study enrollment.
Percentage of participants completing 3 sessions	12 weeks	Feasibility will be assessed by examining retention (\>80% completing 3 sessions).
Percentage of participants using program strategies	12 weeks	Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies).
Treatment Acceptability Questionnaire (TAQ) score	12 weeks	Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The program will be considered acceptable if \>80% of participants rate the program as \>5 out of 7 on the TAQ. A higher score indicates greater acceptability.
Client Satisfaction Questionnaire (CSQ) score	12 weeks	Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The program will be considered acceptable if \>80% of participants rate the program as \>3 out of 4 on the CSQ. A higher score indicates greater acceptability.