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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke Cancer Institute
RECRUITING
Durham
Contact Information
Primary
Smrithi Divakaran, MPH
smrithi.divakaran@duke.edu
919-681-7695
Backup
Michael W Willis
michael.w.willis@duke.edu
919-681-8437
Time Frame
Start Date: 2026-08-11
Estimated Completion Date: 2027-03
Participants
Target number of participants: 26
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Duke University

This content was sourced from clinicaltrials.gov