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

NCT06983691 | Not Yet Recruiting

• 1 other identifier: Pro00117920
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Patient Navigation

Outcome Measures

Primary Outcomes (5)

• Number of participants enrolled

  Feasibility will be assessed by examining pilot study enrollment.

  9 months

• Percentage of participants completing 3 sessions

  Feasibility will be assessed by examining retention (\>80% completing 3 sessions).

  12 weeks

• Percentage of participants using program strategies

  Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies).

  12 weeks

• Treatment Acceptability Questionnaire (TAQ) score

  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.

  12 weeks

• Client Satisfaction Questionnaire (CSQ) score

  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.

  12 weeks

Other Outcomes (12)

• Change in percentage of correct items on a knowledge assessment

  Baseline to 12 weeks

• Change in adherence as measured by number of participants with discontinuation

  Baseline to 12 weeks

• Change in adherence as measured by Voils' medication adherence self-report measure

  Baseline to 12 weeks

Study Arms (1)

Patient Navigation Program

EXPERIMENTAL

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.

Behavioral: Patient Navigation Program

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.

Patient Navigation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• visual or hearing impairment;
• severe cognitive impairment;
• severe mental illness interfering with ability to participate

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smrithi Divakaran, MPH

CONTACT

919-681-7695; smrithi.divakaran@duke.edu

Michael W Willis

CONTACT

919-681-8437; michael.w.willis@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 21, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share