Trial Participation Decision Making in Ovarian Cancer Patients and Their Families

描述(申请人提供)：卵巢癌是最致命的妇科癌症，这种疾病的死亡率在过去50多年中没有变化。梅奥诊所(MC)和其他地方正在开发几种治疗卵巢癌的新疗法。最终，针对这种癌症的新药物的可获得性需要患者登记足够数量的临床试验，然而，5%的成年癌症患者登记参加临床试验，而老年人和妇女(卵巢癌的特征)的参与率往往较低。本研究的重点是了解卵巢癌女性患者参与临床试验的决策，重点是家庭成员的作用和新治疗方法的可接受性。其目的是：(1)描述患者和家属对参与临床试验决策的看法，涉及以下方面：决策过程(信息权重、决策时机、对决策的感知控制、认知与情感焦点)；对参与临床试验的初始态度的感知与实际的不一致，包括如何解决不一致；以及决策结果(决策满意度、决策遗憾)；(2)：描述患者(人口统计)与疾病(早期与晚期；初诊与复发)特征和参与临床试验的决策之间的关系；以及(3)：使用涉及免疫治疗和病毒治疗的方法，探索患者和家庭对特定新治疗试验的态度和可接受性。为了实现这些目标，40名已经接受、拒绝或正在决定参加(任何阶段)试验的上皮性、原发腹膜或输卵管癌患者以及每名1-2名家庭成员(80-120人)将被邀请完成一项了解理论的半结构化访谈。一种对患者和家属的反应进行三角测量的定性方法(获得 另外)提供了最大的机会来确定围绕目前未知的试验决定的具体过程、影响和偏见。MC的卵巢卓越研究专门计划(SPORT)确保这项研究由最先进的科学提供信息，并且结果很容易适用于新兴的临床试验。

DESCRIPTION (provided by applicant): Ovarian cancer is characterized as the most lethal gynecologic cancer and mortality due to this disease has not changed in over 50 years. Several novel therapies against ovarian cancer are in development at Mayo Clinic (MC) and elsewhere. Ultimately, the availability of new agents against this cancer requires patients to enroll in clinial trials in sufficient numbers, yet, <5% of adult patients with cancer are enrolled in clinical trial, and participation among older individuals and women (characteristic of ovarian cancer) is often lower. This study focuses on understanding decision making about clinical trial participation among women with ovarian cancer, with emphases on the role of family members and the acceptability of novel therapeutic approaches. The aims are: (1): Describe patient and family perceptions regarding decisions to participate in a clinical trial with regard to: decision processes (weighting of information, timing of decision, perceived control over decision, cognitive vs. affective focus); perceived vs. actual patient-family discordance in initial attitude toward participation including how discordance was resolved; and decision outcomes (decision satisfaction, decision regret); (2): Describe associations between patient (demographic) and disease (early vs. advanced stage; primary diagnosis vs. recurrence) characteristics and decisions about clinical trial participation; and (3): Explore patient and family attitudes and acceptability surrounding specific novel therapeutic trials using approaches involving immunotherapy and virotherapy. To achieve these aims, 40 patients with epithelial, primary peritoneal, or fallopian tube cancer who have accepted, declined or are currently deciding about (any phase) trial participation and 1-2 family members each (80-120 individuals) will be invited to complete a theory-informed, semi-structured interview. A qualitative approach that triangulates responses from patients and family members (obtained separately) provides the greatest opportunity to identify specific processes, influences, and biases surrounding trial decisions that are presently unknown. An Ovarian Specialized Program of Research Excellence (SPORE) at MC ensures that this study is informed by state-of-the-art science, and that the results are readily applicable to emerging clinical trials.