NCT06983691 · Duke University
Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
Primary outcome measures
Number of participants enrolled
Time frame: 9 months
Feasibility will be assessed by examining pilot study enrollment.
Percentage of participants completing 3 sessions
Time frame: 6 weeks
Feasibility will be assessed by examining retention (\>80% completing 3 sessions).
Percentage of participants using program strategies
Time frame: 6 weeks
Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies).
Treatment Acceptability Questionnaire (TAQ) score
Time frame: 6 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
Time frame: 6 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Collaborators
Pfizer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations