Clinical trial · Interventional
Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2+ Metastatic Breast Cancer (MBC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Navigation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient Navigation Program
- description
- 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.
- interventionNames
- Behavioral: Patient Navigation Program
Primary outcomes (5)
- measure
- Number of participants enrolled
- timeFrame
- 9 months
- description
- Feasibility will be assessed by examining pilot study enrollment.
- measure
- Percentage of participants completing 3 sessions
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available