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

NCT ID: NCT06983691

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-31

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.

Conditions

HER2+ Metastatic Breast Cancer (MBC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient Navigation Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

Smrithi Divakaran, MPH

Role: CONTACT

smrithi.divakaran@duke.edu

919-681-7695

Michael W Willis

Role: CONTACT

michael.w.willis@duke.edu

919-681-8437

Other Identifiers

Pro00117920

Identifier Type: -

Identifier Source: org_study_id