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%的长期儿童癌症幸存者（CCS）经历加速老化： 细胞衰老和衰老相关疾病的过早发作，表现为身体和认知功能 脆弱和脆弱前。加速老化与更频繁和严重的慢性健康并发症有关 影响医疗服务需求的问题。与过去的研究一样，加速衰老的关键研究空白仍然存在。 主要在非西班牙裔白色幸存者中进行，中位治疗后2-3年，评估 在研究环境中的脆弱性。BRIDGES研究（R 01 CA 261881）是我们正在进行的多中心、NCI资助的研究 一项随机对照试验，研究了与社区初级医生共享的医疗保健提供模式， 与癌症中心生存诊所护理相比， 在CCS中我们的R 01的首要目标是更好地满足CCS的医疗保健提供需求， 有可能克服差距的干预措施。这项试验的独特优势包括高比例的 典型的未充分研究的幸存者（拉丁裔，黑人，农村，社会经济弱势），针对早期 仅停止治疗2-4年的幸存者，以及个人和地区一级社会 健康的决定因素。在行政补充资金（PA-20-272）和我们的R 01范围内， 我们寻求解决加速老化研究中的许多空白。在目前的结构内， BRIDGES研究和建立在以前的工作中的调查小组，我们建议测量物理 改良Fried表型的虚弱，PROMIS儿科认知功能的认知障碍- 简式仪器，和细胞衰老与p16 INK 4a表达之间的66个CCS谁将是 在接下来的12个月里被随机分配到癌症中心的生存诊所。可行性得到了 将测量整合到总体生存率诊所访视和先前关于加速老化的研究中， 我们的研究团队种族、民族以及个人和地区层面的健康社会决定因素已经成为 从基线、随机化前评价中获得。我们的具体目标是，在一个种族和民族 CCS的不同样本，以1）确定治疗后早期加速老化的患病率， 通过治疗后2-4年的身体虚弱、认知虚弱和细胞衰老来测量，以及2）测量 个人差异（如保险状况、家庭收入、食物和住房）之间的联系 不安全）和地区一级（例如，邻里安全、获得保健、获得锻炼的天数）的差异 加速老化。变革性影响：如果受癌症影响的儿童癌症幸存者的多样化样本 加速老化可以在治疗后早期识别，并通过常规评估进行， 临床工作人员，我们的数据将支持未来的干预措施，可以改善幸存者的老化轨迹。