BRidging Information Divides and Gaps to Ensure Survivorship: the BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

弥合信息鸿沟和差距，确保生存：旨在提高儿童癌症生存依从性的多层次干预的 BRIDGES 随机对照试验

• 批准号: 10910674
• 负责人: NINA S KADAN-LOTTICK
• 金额: $ 20万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10910674
• 关键词: Acceleration; Address; Adherence; Administrative Supplement; Affect; Aftercare; Age; Aging; Air; Area; Biological Markers; Black race; Blood; CDKN2A gene; Cancer Center; Cancer Survivor; Cancer Survivorship; Caring; Cell Aging; Cell Cycle; Cells; Chemotherapy-Oncologic Procedure; Childhood; Childhood Cancer Survivor Study; Childhood Leukemia; Chronic; Clinic; Clinic Visits; Clinical; Clinical Trials; Cognitive; Cohort Studies; Collaborations; Communities; Data; Disparity; Drug Targeting; Early Diagnosis; Early identification; Elderly; Energy Metabolism; Ensure; Ethnic Origin; Evaluation; Exercise; Exposure to; Financial Hardship; Food; Fracture; Funding; Future; Goals; Grant; Health; Healthcare; Household; Housing; Impaired cognition; Income; Individual; Information Systems; Insurance Coverage; Intervention; Latinx; Lead; Long-Term Survivors; Malignant Childhood Neoplasm; Measurement; Measures; Morbidity - disease rate; Neighborhoods; Not Hispanic or Latino; Patient Outcomes Assessments; Patient Participation; Patients; Pediatric Oncology Group; Peripheral Nervous System Diseases; Persons; Phenotype; Physical Function; Physical activity; Physicians; Prevalence; Publications; Quality of life; Race; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Research Personnel; Risk; Rural; Saint Jude Children' s Research Hospital; Sampling; Second Primary Neoplasms; Seminal; Service delivery model; Siblings; Site; Skeletal Muscle; Structure; Survivors; T-Lymphocyte; Work; childhood cancer survivor; clinical examination; cognitive function; cohort; deprivation; ethnic diversity; exhaustion; experience; frailty; health care availability; health care delivery; improved; indexing; innovation; instrument; kinase inhibitor; muscle form; neighborhood safety; older patient; premature; racial diversity; research clinical testing; social health determinants; social vulnerability; socioeconomic disadvantage; survivorship; tobacco exposure; treatment duration; walkability

Approximately 30-40% of long-term childhood cancer survivors (CCS) experience accelerated aging: the premature onset of cellular senescence and aging-related morbidities manifesting with physical and cognitive frailty and pre-frailty. Accelerated aging is associated with more frequent and severe chronic health complications that impact health care delivery needs. Critical research gaps in accelerating aging remain as past studies were done predominantly in non-Hispanic white survivors, a median of 2-3 decades post-therapy, with assessment of frailty in the research setting. The BRIDGES Study (R01CA261881) is our ongoing multi-site, NCI-funded randomized control trial that investigates a shared health care delivery model with community primary physicians, compared to cancer center survivorship clinic care, to provide recommended surveillance for chronic conditions among CCS. Our R01’s overarching goal is to better meet the health care delivery needs of CCS with an intervention that can potentially overcome disparities. Unique strengths of this trial include high proportions of typically understudied survivors (Latinx, Black, rural, socioeconomically disadvantaged), targeting of early survivors who are only 2-4 years off-therapy, and baseline assessment of individual and area-level social determinants of health. With administrative supplemental funding (PA-20-272) and within the scope of our R01, we seek to address many of the gaps in accelerated aging research. Within the structure of the ongoing BRIDGES study and building on previous work within the investigator team, we propose to measure physical frailty with the modified Fried Phenotype, cognitive impairment with the PROMIS Pediatric Cognitive Function– Short Form instrument, and cellular senescence with p16INK4a expression among the 66 CCS who will be randomized to cancer center survivorship clinic over the next 12 months. Feasibility is supported by the integration of measures into the overall survivorship clinic visit and previous research on accelerated aging by our research team. Race, ethnicity, and individual- and area-level social determinants of health are already available from the baseline, pre-randomization evaluation. Our Specific Aims are, in a racially and ethnically diverse sample of CCS, to 1) Determine the prevalence of accelerated aging early in the post-treatment period, as measured by physical frailty, cognitive frailty, and cellular senescence 2-4 years post-therapy, and 2) Measure associations between disparities in individual (e.g. insurance status, household income, food and housing insecurity) and area-level (e.g. neighborhood safety, access to health care, days access to exercise) disparities and accelerated aging. Transformative Impact: If a diverse sample of childhood cancer survivors affected by accelerating aging can be identified early in the post-therapy period and with routine assessments done by clinical staff, our data would support future interventions that could improve survivors’ aging trajectory.

大约30-40％的长期儿童癌症存活（CCS）经历了加速衰老： 细胞感应和与衰老相关的病因的过早发作表现为身体和认知 脆弱和预付。加速衰老与更频繁和严重的慢性健康并发症有关 这会影响医疗保健的需求。由于过去的研究是 在接受评估后，主要是在非西班牙裔白色冲浪者中进行2-3年的中位数 研究环境中的脆弱。桥梁研究（R01CA261881）是我们正在进行的多站点，NCI资助 随机对照试验调查了与社区小学医生共享的医疗保健交付模型， 与癌症中心的生存诊所护理相比，为慢性条件提供建议的监视 在CC中。我们的R01的总体目标是更好地满足CCS的医疗保健服务需求 可能会克服分布的干预措施。该试验的独特优势包括高比例 通常了解生存（拉丁裔，黑色，粗糙，社会经济处于不利地位），针对早期 仅2 - 4年外的幸存者，以及对个人和地区社会的基线评估 健康的决定因素。具有行政补充资金（PA-20-272），并在我们的R01范围内 我们试图解决加速衰老研究中的许多差距。在正在进行的结构内 桥梁研究和基础研究者团队中的先前工作，我们建议衡量身体 脆弱的炸液表型，具有Promis小儿认知功能的认知障碍 - 短形式仪器和在66 cc中具有p16ink4a表达的细胞感应 在接下来的12个月内随机分配到癌症中心的生存诊所。可行性得到了 将措施纳入整体生存诊所访问和先前关于加速衰老的研究 我们的研究团队。种族，种族以及个人和地区和地区级的健康决定者已经是 可从基线，随机化评估。我们的具体目标是在一个大致和种族上 CC的不同样本，至1）确定治疗后早期加速衰老的患病率， 通过身体脆弱，认知脆弱和细胞感应后2 - 4年的衡量，2）测量 个人分布之间的关联（例如保险状况，家庭收入，食品和住房 不安全感）和区域级别（例如，邻里安全，获得医疗保健，锻炼天数）差异 和加速衰老。变革性影响：如果儿童癌症的潜水样本生存受到影响 可以在治疗后的早期确定加速衰老，并通过常规评估 临床人员，我们的数据将支持未来的干预措施，这些干预措施可以改善生存的衰老轨迹。