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

EMPOWER 研究：促进儿童癌症幸存者的 BC 筛查 行政补充

• 批准号: 10166071
• 负责人: Jennifer S Ford
• 金额: $ 15万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166071
• 关键词: Administrative Supplement; Adult; Age; Age-Years; Anthracycline; Breast; Breast Cancer Early Detection; Breast Cancer Risk Factor; Breast Magnetic Resonance Imaging; Cardiovascular Diseases; Cardiovascular system; Caring; Categories; Chest; Childhood Cancer Survivor Study; Chronic; Chronic Disease; Chronic Obstructive Airway Disease; Cohort Studies; Congestive; Coronary Arteriosclerosis; Data; Development; Diagnosis; Elements; Enrollment; Event; Female; Funding; Future; Guideline Adherence; Health; Heart Diseases; Incidence; Intervention; Kidney; Life; Lung; Malignant Childhood Neoplasm; Malignant Neoplasms; Mammary Gland Parenchyma; Mammography; Mental Depression; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Patient risk; Patients; Primary Care Physician; Provider; Radiation; Radiation therapy; Relative Risks; Research; Risk; Risk stratification; Screening for cancer; Second Primary Cancers; Secondary to; Specific qualifier value; Survivors; Testing; Time; Transplantation; United Kingdom; Woman; Women' s Health; Work; adverse event risk; base; breast imaging; chemotherapy; childhood cancer survivor; clinical practice; cohort; experience; follow-up; high risk; improved; individual patient; interest; kidney dysfunction; mortality; mortality risk; programs; repository; response; screening; survivorship; tool; young woman

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.

摘要 本申请是为了回应特别利益通知（NOSI）而提交的，该通知被确定为不- CA-20-038 儿童癌症幸存者处于不良事件的高风险中，大约三分之一的常见癌症幸存者 儿童癌症将在40岁之前经历严重或致命的晚期事件。这些事件的风险几乎 女性发生的可能性是男性的两倍，并且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，我们目前无法提供初级保健医生， 对患者在特定时间段内发生特定事件的风险提供更具体的指导。 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， 用于帮助指导和鼓励最佳的生存护理。 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。 队列研究在英国（UK）开发的现有风险计算器预测 5-年严重事件发生率。为了预测风险，我们将使用英国计算器，它提供了简化的风险 儿童癌症幸存者的分层作为其治疗的功能。患者将被分配风险 根据英国风险模型，根据他们接受的治疗，将他们分为低、中、高风险。我们 然后将测试该模型预测指定5年窗口内严重事件发生率的能力。 目的1：使用英国风险分类预测CCSS队列中女性的长期总生存期。 使用英国的计算器，我们将女性分为低，中，高风险类别，并比较长期- 按风险类别列出的总生存期。我们将进行我们的研究，生存率定义为A）10年后 初次诊断，B）诊断后15年，C）25岁，和D）30岁，以评估到何种程度 这些风险可以在一段时间内得到一致的评估。 目的2：预测CCSS队列中严重慢性健康状况（3-5级）的发生率， 英国风险分类我们将研究严重慢性健康状况的发生率，包括 心血管、肺、肾疾病、抑郁和继发性恶性肿瘤的发展。我们将 在A）初次诊断后10年，B）诊断后15年，C）25岁， D. 30岁以上。妇女将仅限于那些没有任何慢性健康状况的证据， 时间点，重点是确定以前健康女性的晚期事件。 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 个性化的中期风险状况，以鼓励适当和最佳的生存护理。