Clinical trial NCT06983691: Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
Official title: Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HER2+ Metastatic Breast Cancer (MBC)
Keywords: Patient Navigation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2025-05-21
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of participants enrolled
timeFrame: 9 months
measure: Percentage of participants completing 3 sessions
timeFrame: 12 weeks
measure: Percentage of participants using program strategies
timeFrame: 12 weeks
measure: Treatment Acceptability Questionnaire (TAQ) score
timeFrame: 12 weeks
measure: Client Satisfaction Questionnaire (CSQ) score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: Change in percentage of correct items on a knowledge assessment
timeFrame: Baseline to 12 weeks
measure: Change in adherence as measured by number of participants with discontinuation
timeFrame: Baseline to 12 weeks
measure: Change in adherence as measured by Voils' medication adherence self-report measure
timeFrame: Baseline to 12 weeks
measure: Change in symptom severity as measured by the MD Anderson Symptom Inventory (MDASI)
timeFrame: Baseline to 12 weeks
measure: Change in symptom interference as measured by the MD Anderson Symptom Inventory (MDASI)
timeFrame: Baseline to 12 weeks
measure: Change in the impact of hand-foot syndrome (HFS) on quality of life as measured by the Hand-Foot Syndrome Quality of Life Scale (HFS-14)
timeFrame: Baseline to 12 weeks
measure: Change in anxiety severity as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4-item Short-Form
timeFrame: Baseline to 12 weeks
measure: Change in depression severity as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4-item Short-Form
timeFrame: Baseline to 12 weeks
measure: Change in quality of life as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: Baseline to 12 weeks
measure: Change in self-efficacy as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Symptoms 4-item Short Form
timeFrame: Baseline to 12 weeks
measure: Change in self-efficacy as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions 4-item Short Form
timeFrame: Baseline to 12 weeks
measure: Change in patient activation as measured by the Patient Activation Measure (PAM)
timeFrame: Baseline to 12 weeks
Locations:
Study officials:
affiliation: Duke University
name: Rebecca Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References: