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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks
  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a nurse-led support program for women with HER2-positive breast cancer that has spread to other parts of the body and who take tucatinib, trastuzumab, and capecitabine. The program lasts about 6 weeks and helps with understanding treatment, managing symptoms, taking medicines, and coping. The study asks whether the program is practical to offer and acceptable to patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Assigned female at birth.
  • Age 18 or older when joining.
  • Have HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein that helps cancer cells grow.
  • Are taking tucatinib together with capecitabine and trastuzumab.
  • Can speak and read English.

Who can't join

  • Have trouble seeing or hearing.
  • Have severe problems with thinking or memory.
  • Have a severe mental illness that makes it hard to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC