Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Navigation Program.
- Who it may be relevant to
- Registry conditions: HER2+ Metastatic Breast Cancer (MBC). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
Overview
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]
- Percentage of participants completing 3 sessions [Time frame: 6 weeks]
- Percentage of participants using program strategies [Time frame: 6 weeks]
- Treatment Acceptability Questionnaire (TAQ) score [Time frame: 6 weeks]
- Client Satisfaction Questionnaire (CSQ) score [Time frame: 6 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06983691 · Pro00117920