Trial Participation Decision Making in Ovarian Cancer Patients and Their Families

描述（由申请人提供）：卵巢癌的特征是最致命的妇科癌症，50多年来这种疾病的死亡率没有变化。马约诊所（MC）和其他地方正在开发几种针对卵巢癌的新疗法。最终，针对这种癌症的新药的可用性要求患者参加足够数量的临床试验，然而，<5%的成年癌症患者参加了临床试验，老年人和女性（卵巢癌的特征）的参与率通常较低。本研究的重点是了解卵巢癌妇女参与临床试验的决策，重点是家庭成员的作用和新的治疗方法的可接受性。其目标是：（1）：描述患者和家属对参与临床试验的决定的看法，包括：决策过程（信息权重、决策时间、对决策的感知控制、认知与情感焦点）;患者-家庭在参与初始态度方面的感知与实际不一致，包括如何解决不一致;以及决策结果（决策满意度，决策后悔）;（2）：描述患者之间的关联（人口）和疾病（早期与晚期;初步诊断与复发）特征和参与临床试验的决定;以及（3）：探索患者和家庭的态度和接受周围的具体新的治疗试验使用的方法涉及免疫疗法和病毒疗法。为了实现这些目标，将邀请40例接受、拒绝或目前正在决定（任何阶段）参加试验的上皮癌、原发性腹膜癌或输卵管癌患者和1-2名家庭成员（80-120人）完成一项理论知情的半结构化访谈。一种定性的方法，从病人和家庭成员的反应三角（获得 单独）提供了最大的机会，以确定具体的过程，影响，和偏见周围的审判决定，目前是未知的。MC的卵巢专业研究卓越计划（SPORE）确保这项研究得到最先进的科学信息，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.