Evaluation of Cardiovascular Outcomes Among Childhood Cancer Survivors

儿童癌症幸存者的心血管结局评估

• 批准号: 7792610
• 负责人: CHERYL Lorane COX
• 金额: $ 67.68万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7792610
• 关键词: Adherence; Adolescent; Adult; Advanced Practice Nurse; Affect; Age; Anthracyclines; Behavioral; Belief; Cancer Survivor; Cardiac; Cardiac Death; Cardiovascular Diseases; Cardiovascular system; Caring; Characteristics; Chest; Child; Childhood; Childhood Cancer Survivor Study; Clinical Trials; Counseling; Diagnosis; Echocardiography; Effectiveness of Interventions; Eligibility Determination; Evaluation; Failure; Frequencies; Fright; Future; Gender; Health; Health behavior; Image; Image Analysis; Impact evaluation; Individual; Informed Consent; Intervention; Knowledge; Left; Life Style; Magnetic Resonance Imaging; Mails; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Mediating; Medical; Methods; Modeling; Modification; Monitor; Morbidity - disease rate; Motivation; Outcome; Population; Population Study; Populations at Risk; Preventive; Provider; Quality of Care; Radiation; Randomized; Readiness; Recommendation; Recruitment Activity; Research; Research Design; Research Personnel; Resources; Risk; Risk Management; Scanning; Screening procedure; Self Efficacy; Structure; Survivors; Techniques; Telephone; Testing; Time; Treatment Efficacy; Upper arm; Ventricular; base; cancer diagnosis; cancer therapy; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular risk factor; chemotherapy; childhood cancer survivor; cohort; cost; cost effectiveness; design; diagnosis standard; follow-up; forging; group counseling; improved; irradiation; mortality; motivational enhancement therapy; multidisciplinary; premature; primary outcome; public health relevance; response; sex; social; standard care; standard of care; theories; therapy development; uptake; young adult

DESCRIPTION (provided by applicant): Nearly 80% of children and adolescents with cancer survive 5 or more years after diagnosis and are effectively cured. A significant number of childhood cancer survivors are at risk for cardiovascular (CV) disease resulting from treatment with anthracycline chemotherapy and radiation to CV structures. Previous studies indicate that the frequency of premature CV disease is substantial in this young adult population, and it significantly increases the risk of early mortality. Because most at-risk childhood cancer survivors are asymptomatic, periodic monitoring for late CV complications is critical. However, few survivors undergo CV screening and social and behavioral factors such as knowledge deficits, lack of access to preventive care, and unhealthy lifestyles may exacerbate risk of CV complications. Prevention of CV disease in this growing, at-risk population requires individualized information based on specific treatment exposures and individualized support based on important behavioral constructs. This proposal aims to test a 2-tiered tailored intervention-Evaluation of Cardiovascular Health Outcomes among Survivors (ECHOS)-designed to inform childhood cancer survivors about their individual cardiac risk and follow-up recommendations and to provide motivational support for CV screening. The ECHOS trial will test if the addition of telephone motivational interviewing, tailored to behavioral constructs, is superior to the current standard of care in increasing survivors' CV screening; 815 adult survivors whose cancer was treated with chest radiation and/or anthracycline chemotherapy and who have not had CV screening in the past five years will be eligible to participate. Of these, 652 will be randomly assigned to receive either: 1) a mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care) or 2) standard care plus telephone counseling by an advanced- practice nurse that incorporates motivational interviewing techniques tailored to survivors' baseline measures of knowledge, beliefs, readiness for follow-up, motivation, self-efficacy, affect, fear, and survivor-provider interaction. The primary outcome is CV screening adherence, defined as completion or failure to complete an imaging evaluation of left ventricular systolic function (i.e., echocardiogram, multiple uptake gated acquisition scan, or cardiac magnetic resonance imaging). The study population will be recruited from a well- defined cohort of childhood cancer survivors participating in the Childhood Cancer Survivor Study (CCSS). A broad-based health behavior model adapted to childhood cancer survivors will guide the intervention. Secondary aims will evaluate the intervention's cost-effectiveness as well as intervention-related changes in survivors' knowledge, motivation, fear, beliefs, affect, readiness for medical follow-up, and self-efficacy. Knowledge derived from this research will provide the background for future evaluations of the impact of health screening on improving quality of care and reducing cancer-related morbidity in childhood cancer survivors. PUBLIC HEALTH RELEVANCE: Because most pediatric malignancies can now be cured, there is an increasing number of survivors at risk of late cardiovascular (CV) complications of anthracycline chemotherapy and/or irradiation of CV structures. In this group, the risk of cardiac death is 6 to 10 times that of the age- and gender-matched population, yet few adults surviving childhood cancer undergo CV screening. CV complications may be exacerbated by social and behavioral factors, such as knowledge deficits, lack of access to preventive care, and unhealthy lifestyle. We therefore propose to test a 2-armed tailored intervention-Evaluation of Cardiovascular Health Outcomes among Survivors (ECHOS)-designed to provide adult childhood cancer survivors with their individual cardiac risk and follow-up recommendations and to provide motivational support to promote CV screening. We expect the intervention to increase childhood cancer survivors' CV screening adherence, and therefore potentially significantly modify the morbidity and mortality of CV disease in this at-risk population.

描述（由申请人提供）：近80%的儿童和青少年癌症患者在诊断后存活5年或更长时间，并得到有效治愈。大量儿童癌症幸存者因蒽环类药物化疗和CV结构放疗而面临心血管（CV）疾病的风险。先前的研究表明，早发CV疾病的频率在这一年轻成人人群中很高，并显著增加了早期死亡的风险。由于大多数高危儿童癌症幸存者无症状，因此定期监测晚期CV并发症至关重要。然而，很少有幸存者接受CV筛查，社会和行为因素，如知识缺乏，缺乏预防保健和不健康的生活方式可能会加剧CV并发症的风险。在这一不断增长的高危人群中预防CV疾病需要基于特定治疗暴露的个体化信息和基于重要行为结构的个体化支持。该提案旨在测试一种2层定制干预-幸存者心血管健康结局评价（ECHOS）-旨在告知儿童癌症幸存者其个人心脏风险和随访建议，并为CV筛查提供动机支持。ECHOS试验将测试增加针对行为结构的电话动机访谈在增加幸存者的CV筛查方面是否上级当前的护理标准; 815名接受胸部放疗和/或蒽环类药物化疗的癌症成年幸存者以及在过去五年中没有进行CV筛查的人将有资格参加。其中，652人将被随机分配接受：1）邮寄的个性化癌症治疗总结，包括CV随访和生活方式改变的建议（标准护理）或2）标准护理加电话咨询，由先进的实践护士，结合动机访谈技术，适合幸存者的基线措施的知识，信念，准备跟进，动机，自我效能，影响、恐惧和幸存者与提供者的互动。主要结局是CV筛查依从性，定义为完成或未能完成左心室收缩功能的成像评价（即，超声心动图、多摄取门控采集扫描或心脏磁共振成像）。研究人群将从参与儿童癌症幸存者研究（CCSS）的明确定义的儿童癌症幸存者队列中招募。一个适应儿童癌症幸存者的基础广泛的健康行为模型将指导干预。次要目标将评估干预措施的成本效益以及幸存者的知识、动机、恐惧、信念、情感、医疗随访准备和自我效能方面与干预措施相关的变化。从这项研究中获得的知识将为未来评估健康筛查对提高儿童癌症幸存者护理质量和降低癌症相关发病率的影响提供背景。 公共卫生相关性：由于大多数小儿恶性肿瘤现在可以治愈，有越来越多的幸存者在蒽环类药物化疗和/或CV结构的照射的晚期心血管（CV）并发症的风险。在这组人群中，心源性死亡的风险是年龄和性别匹配人群的6至10倍，但很少有儿童癌症幸存的成年人接受CV筛查。CV并发症可能会因社会和行为因素而加剧，例如知识缺乏，缺乏预防性护理和不健康的生活方式。因此，我们建议测试一种双臂定制干预-幸存者心血管健康结局评价（ECHOS）-旨在为成年儿童癌症幸存者提供个人心脏风险和随访建议，并提供激励支持以促进CV筛查。我们预计干预措施将增加儿童癌症幸存者的CV筛查依从性，因此可能显着改变这一高危人群中CV疾病的发病率和死亡率。