EMPOWER Study: Promoting BC Screening in Women Who Survived Childhood Cancer Administrative Supplement

摘要 本申请是针对特别关注通知(NOSI)而提交的，该通知被确定为不- CA-20-038。 儿童癌症幸存者发生不良事件的风险很高，而大约三分之一的普通癌症幸存者 儿童癌症将在40岁之前经历一次严重或致命的晚期事件。这些事件的风险几乎是 发生在女性身上的可能性是女性的两倍，可能包括几种严重的慢性健康问题。然而，尽管已知 相对风险增加，特别是在女性中，我们目前无法为初级保健医生和 为患者提供关于在特定时间段内发生特定事件的风险的更具体指导。 因此，迫切需要为这些患者及其提供者提供实用的风险预测工具，以便 用于帮助指导和鼓励最佳生存护理。 在这项研究中，我们将使用儿童癌症幸存者研究(CCSS)中所有成年女性幸存者的数据 调查英国(UK)开发的现有风险计算器预测 严重事件的5年比率。为了预测风险，我们将使用英国计算器，它提供简化的风险 儿童癌症幸存者的分层作为其治疗的一个功能。患者将被分配一种风险 根据他们根据英国风险模型接受的治疗，分为低、中和高三个等级。我们 然后，将测试该模型预测特定5年窗口内严重事件比率的能力。 目的1：使用英国风险分类来预测CCSS队列中女性的长期总体存活率。 使用英国计算器，我们将女性划分为低、中或高风险类别，并将长期风险与 按风险类别划分的总体存活率。我们将在A)10年后进行生存定义的研究 初步诊断，B)诊断后15年，C)25岁，D)30岁评估程度 随着时间的推移，这些风险可以得到一致的评估。 目的2：预测CCSS队列中严重慢性健康状况(3-5级)的发生率 英国的风险分类。我们将检查严重的慢性健康状况的发生率，包括 心血管、肺部、肾脏疾病、抑郁和继发性恶性肿瘤的发展。我们会 在A)首次诊断后10年，B)诊断后15年，C)25岁， D)30岁。女性将被限制在那些没有任何慢性健康状况证据的人 时间点，重点是确定既往健康女性的事件晚期事件。 这项研究是一项重要的妇女健康倡议，将为患者和提供者提供 个体化的中期风险概况，以鼓励适当和最佳的生存护理。

ABSTRACT This application is being submitted in response to theNotice of Special Interest (NOSI) identified as NOT- CA-20-038. Childhood cancer survivors are at high risk of adverse events and roughly a third of survivors of common childhood cancers will experience a serious or lethal late event by age 40. The risk of these events are almost twice as likely to occur in women, and can include several serious chronic health. However, despite the known increased relative risks, particularly in females, we are currently unable to provide primary care physicians and patients with more specific guidance as to the risk of having a specific event within a specified period of time. There is therefore a critical need for practical risk prediction tools for these patients and their providers that can be used to help guide and encourage optimal survivorship care. In this study, we will use data from all adult female survivors in the Childhood Cancer Survivors Study (CCSS) cohort to investigate the ability of an existing risk calculator developed in the United Kingdom (UK) to predict the 5-year rate of serious events. To predict risk, we will use the UK calculator, which provides simplified risk stratification for childhood cancer survivors as a function of their treatment. Patients will be assigned either a risk of low, intermediate, and high based on the treatment they received in accordance with the UK risk model. We will then test the model’s ability to predict the rate of serious events within specified 5-year windows. Aim 1: To predict long-term overall survival in females within the CCSS cohort using the UK risk categorization. Using the UK calculator we will place females in low, intermediate, or high risk categories and compare long- term overall survival by risk category. We will conduct our study with survival being defined at A) 10 years after initial diagnosis, B) 15 years after diagnosis, C) 25 years of age, and D) 30 years of age to assess to what extent these risks can be consistently assessed over time. Aim 2: To predict the incidence of serious chronic health conditions (grade 3-5) within the CCSS cohort using the UK risk categorization. We will examine the incidence of serious chronic health conditions including cardiovascular, pulmonary, renal conditions, depression, and development of secondary malignancies. We will assess these events both at A) 10 years after initial diagnosis, B) 15 years after diagnosis, C) 25 years of age, and D) 30 years of age. Women will be limited to those without any evidence of chronic health conditions at each time point, with the focus being to identify incident late events in previously healthy women. This study is an important women’s health initiative which will provide patients and providers with individualized, intermediate-term risk profiles to encourage appropriate and optimal survivorship care.