A Decision Aid with HRQL Assessment to Reduce Costs in the Treatment of NSCLC

通过 HRQL 评估进行决策辅助，以降低 NSCLC 的治疗成本

• 批准号: 8509626
• 负责人: Richard G Gralla
• 金额: $ 60.88万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8509626
• 关键词: Address; Affect; Agreement; Appointment; Asians; Cancer Center; Caring; Chemotherapy-Oncologic Procedure; Clinic; Clinical; Clinical Management; Clinical Trials; Collaborations; Communication; Computer Assisted; Conflict (Psychology); Coupled; Data; Decision Aid; Decision Making; Dependence; Devices; Electronics; Equilibrium; Evaluation; Family; Goals; Hand; Healthcare; Image; International; Intervention; Lead; Litigation; Magnetic Resonance Imaging; Malignant neoplasm of lung; Measures; Methods; Monitor; Non-Small-Cell Lung Carcinoma; Nurses; Outcome; Outcome Assessment; Outpatients; Paper; Patient Care; Patient Outcomes Assessments; Patients; Pemetrexed; Perception; Performance; Phase; Physicians; Positron-Emission Tomography; Preparation; Process; Protocols documentation; Quality of life; Quality-of-Life Assessment; Radiation; Randomized; Randomized Clinical Trials; Regrets; Reporting; Research Personnel; Risk; Sampling; Solutions; Subgroup; Symptoms; System; Systemic Therapy; Testing; Time; Visit; arm; base; cancer therapy; chemotherapy; clinical decision-making; clinical practice; computerized; cost; design; docetaxel; evidence base; expectation; health related quality of life; improved; innovation; instrument; novel diagnostics; phase 3 study; programs; prospective; response; screening; shared decision making; statistics; tool; treatment duration

DESCRIPTION (provided by applicant): Appropriate utilization of treatment with systemic therapy remains problematic in advanced lung cancer. A major issue continues to be over-treatment. Contributors to this include barriers in communication concerning patients' wishes and goals, lack of formal monitoring of symptoms using validated health-related quality of life (QL) and patient reported outcomes (PROs) assessment, and over-dependence on imaging studies as the major and often sole assessment tool. All of these factors make quality decision making more difficult and can lead to decisional conflict and patient and family regret with treatment. The primary specific aim is to test the hypothesis that use of a decision aid to enhance informed, shared decision making coupled with QL assessment in patients with advanced lung cancer receiving first- or second-line therapy will lead to a reduction in two major contributors of cost (number of chemotherapy cycles administered and the number of advanced imaging studies [CT, MRI, PET] related to treatment decisions) compared with the control arm. Secondary aims are: 1) To test the hypothesis that patients with advanced lung cancer who receive an intervention (decision aid coupled with immediate QL-PRO results) will have reduced decisional conflict, and reduced decisional regret related to the decision-making process, than those who do not; and 2) to explore the hypothesis that patients with advanced lung cancer who have greater agreement with their chosen supporter (less difference in perception of QL-PROs between the patient and the supporter) will have fewer chemotherapy cycles, than those who do not have close agreement. This phase III, two-arm, prospective, randomized clinical trial (RCT) will test the use of a decision aid for patients with advanced lung cancer, coupled with the validated computer-assisted QL instrument ("eLCSS-QL"), to provide immediate QL-PRO results over the treatment period. A repeated measures design will obtain QL assessment at baseline, every 3 weeks while chemotherapy is given, and at the completion of chemotherapy. This study will use a pretest/ posttest design covering timing for each of two consequential decisions of cancer chemotherapy: Decision 1 ("Changing Chemotherapy"), and Decision 2 ("Stopping Anti-Cancer Treatment"). There will be three entry points: patients can be entered into the trial either at their initial chemotherapy, or at the time of starting 2nd- or 3rd-line chemotherapy. A stratified block randomization design will be used in which strata are determined by two variables: line of therapy and presenting quality of life. This RCT will be conducted in the outpatient setting at three cancer centers in three states. The sample will include 196 patients with advanced non-small cell lung cancer and their chosen supporter (if available). The sampling plan will include serially screening the clinic appointment roster in the clinics. QL-PRO assessment, decisional conflict, and decisional regret will be used to evaluate response to the decision aid. A protocol will be followed by the physician and study nurse at each visit. Descriptive statistics, subgroup analyses (t-test), and GLM method will be used for analyses.

描述（由申请人提供）：在晚期肺癌中，适当利用全身治疗仍然存在问题。一个主要问题仍然是过度治疗。造成这种情况的原因包括关于患者愿望和目标的沟通障碍、缺乏使用经过验证的健康相关生活质量 (QL) 和患者报告结果 (PRO) 评估对症状进行正式监测，以及过度依赖影像学研究作为主要手段并且通常是唯一的评估工具。所有这些因素使得做出高质量决策变得更加困难，并可能导致决策冲突以及患者和家属对治疗的遗憾。主要具体目的是检验以下假设：使用决策辅助工具来增强接受一线或二线治疗的晚期肺癌患者的知情、共同决策，再加上 QL 评估，将导致两个主要因素的减少。与对照组相比的成本（化疗周期数以及与治疗决策相关的高级成像研究 [CT、MRI、PET] 的数量）。次要目标是：1) 检验以下假设：接受干预（决策辅助加上即时 QL-PRO 结果）的晚期肺癌患者将减少决策冲突，并减少与决策过程相关的决策后悔，那些不这样做的人； 2) 探讨这样的假设：与所选支持者的一致性较高（患者与支持者之间对 QL-PRO 的认知差异较小）的晚期肺癌患者，与那些没有接近的患者相比，化疗周期会更少。协议。这项 III 期、双组、前瞻性、随机临床试验 (RCT) 将测试晚期肺癌患者决策辅助的使用情况，并结合经过验证的计算机辅助 QL 仪器（“eLCSS-QL”），以提供在治疗期间立即获得 QL-PRO 结果。重复测量设计将在基线、化疗期间每 3 周以及化疗完成时获得 QL 评估。本研究将使用预测试/后测试设计，涵盖癌症化疗的两个后续决策的时间安排：决策 1（“改变化疗”）和决策 2（“停止抗癌治疗”）。将有三个切入点：患者可以在初次化疗时或开始二线或三线化疗时进入试验。将使用分层区组随机化设计，其中分层由两个变量确定：治疗方案和生活质量。这项随机对照试验将在三个州三个癌症中心的门诊进行。该样本将包括 196 名晚期非小细胞肺癌患者及其选择的支持者（如果有）。抽样计划将包括对诊所的诊所预约名册进行连续筛查。 QL-PRO 评估、决策冲突和决策后悔将用于评估对决策辅助的响应。医生和研究护士在每次就诊时都会遵循协议。将使用描述性统计、亚组分析（t 检验）和 GLM 方法进行分析。