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) 经历加速衰老： 细胞衰老过早发生以及与衰老相关的疾病，表现为身体和认知方面的症状 衰弱和衰弱前期与更频繁和更严重的慢性健康并发症有关。 与过去的研究一样，加速老龄化方面的关键研究差距仍然存在。 主要针对非西班牙裔白人幸存者进行，中位治疗后 2-3 年，并进行评估 BRIDGES 研究 (R01CA261881) 是我们正在进行的、由 NCI 资助的多站点研究。 随机对照试验，调查与社区初级医生共享医疗保健提供模式， 与癌症中心生存诊所护理相比，提供推荐的慢性病监测 我们 R01 的总体目标是更好地满足 CCS 的医疗保健提供需求。 这项试验的独特优势包括高比例的干预措施。 通常未被充分研究的幸存者（拉丁裔、黑人、农村、社会经济弱势群体），针对早期 仅结束治疗 2-4 年的幸存者，以及个人和地区级社会的基线评估 通过行政补充资金 (PA-20-272) 并在我们的 R01 范围内， 我们寻求在正在进行的加速衰老研究的结构内解决许多空白。 BRIDGES 研究并以研究者团队之前的工作为基础，我们建议测量身体 改良 Fried 表型导致的虚弱，PROMIS 儿科认知功能导致的认知障碍 – 简式仪器，以及 66 个 CCS 中 p16INK4a 表达的细胞衰老 在接下来的 12 个月内随机分配到癌症中心生存诊所的可行性得到了以下机构的支持。 将措施纳入整体生存门诊就诊和之前关于加速衰老的研究 我们的研究团队已经确定了种族、民族以及个人和地区层面的健康社会决定因素。 从基线、预随机化评估中可以看出，我们的具体目标是在种族和民族方面。 CCS 的不同样本，1) 确定治疗后早期加速衰老的患病率， 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 个人差异之间的关联（例如保险状况、家庭收入、食物和住房） 不安全）和地区层面（例如社区安全、获得医疗保健、锻炼天数）的差异 和加速老龄化：如果儿童癌症幸存者的不同样本受到影响。 加速衰老可以在治疗后早期通过常规评估来识别 临床工作人员，我们的数据将支持未来的干预措施，从而改善幸存者的衰老轨迹。