Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Development of materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung cancer as a standard component of clinical care
研究概览
简要总结
This trial studies the use of genetics and shared decision making in improving care for patients with stage IVA-C non-small cell lung cancer. Developing educational tools may help patients with non-small cell lung cancer to increase patient treatment knowledge, reduce decisional conflict, and promote treatment shared decision making with their health care providers.
详细描述
PRIMARY OBJECTIVES:
I. Use the information on genomic tumor diagnostics, provider treatment recommendations, and patient and provider feedback on the treatment decision making process, which will be used to develop materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung carcinoma (NSCLC) as a standard component of clinical care.
SECONDARY OBJECTIVES:
I. Pilot test the adapted DCP in a subset of patients to determine the feasibility of delivering the DCP session.
II. Assess DCP effects on patient treatment knowledge and decisional conflict. III. Assess treatment choice.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed with advanced NSCLC (stage IV a-c) that are wild-type for activating genetic alterations (EGFR, ROS 1, and ALK).
- •May or may not be candidates for immune checkpoint therapy.
- •May have had 1-any number of prior systemic therapy regimens.
- •If prior systemic regimen, must have progression disease at time of evaluation.
- •Untreated brain metastases permitted.
- •Completed pathological analysis of tumor tissue.
- •Patients who have exhausted targeting therapy options.
- •Can speak and read English.
- •All participants must be willing to comply with all study procedures and be available for the duration of the study.
- •Providers: Those who treat NSCLC patients as described above.
排除标准
- •There are no specific exclusions in this trial for particular medical conditions, comorbidities, or performance status. Any patient deemed appropriate to be considered for evaluation and/or treatment would be appropriate to include in this trial.
结局指标
主要结局
Development of materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung cancer as a standard component of clinical care
时间窗: Up to 6 weeks
Results will be reported descriptively. A Decision Counseling Program (DCP) is a tool that allows patients and physicians to engage shared decision making. The DCP will be created based on genetic tumor diagnostics, provider treatment recommendations, and feedback from patients and providers gathered from interviews.
次要结局
- Treatment choice of patients after receiving counseling(Up to 60 days)
- Feasibility of the adapted DCP in a subset of patients: proportion of consenting patients who complete the DCP(Up to 6 weeks)
- DCP effects on patient treatment knowledge and decisional conflict(Up to 60 days)