Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Percentage of participants completing 3 sessions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •visual or hearing impairment;
- •severe cognitive impairment;
- •severe mental illness interfering with ability to participate
研究组 & 干预措施
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.
干预措施: Patient Navigation Program (Behavioral)
结局指标
主要结局
Percentage of participants completing 3 sessions
时间窗: 6 weeks
Feasibility will be assessed by examining retention (\>80% completing 3 sessions).
Percentage of participants using program strategies
时间窗: 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
时间窗: 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
时间窗: 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.
Number of participants enrolled
时间窗: 9 months
Feasibility will be assessed by examining pilot study enrollment.
次要结局
未报告次要终点