Cytera C, Baust K, Borgmann-Staudt A, Calaminus G, Egger-Heidrich K, Faber J, Grabow D, Halbsguth T, Kock-Schopenhauer A, König I R, Michaelis S, Neumann A, Puzik A, Schuster S, Wolters F, Arendt C, Sleimann M, Langer T, Gebauer J
Paediatric Haematology and Oncology, University Hospital of Schleswig-Holstein, Campus Luebeck, Luebeck, Germany.
Department for Paediatric Haematology/Oncology, University Hospital Bonn, Bonn, Germany.
BMC Cancer. 2025 May 22;25(1):921. doi: 10.1186/s12885-025-14355-x.
Late effects can occur years to decades after cancer therapy, resulting in morbidity and reduced health-related quality of life. Clinical long-term follow-up (LTFU) enables timely diagnosis and treatment of these sequelae. So far, only a minority of childhood cancer survivors (CCS) in Germany regularly visit LTFU care facilities. The LE-Na study aims to: 1. implement and/or improve LTFU care structures for adult CCS in Germany, 2. inform former patients about late effects and LTFU care centers, 3. create a basis for future research by building up a central database, consent management and infrastructure, 4. establish a clinical LTFU cohort of adult CCS in Germany, 5. evaluate the implementation of the LFTU care, 6. enable the expansion of LTFU care structures nationwide, 7. integrate the developed LTFU care structures into the standard health care system.
Within five years, approximately 5000 CCS will be invited to visit one of the 10 LTFU centers in Germany. Study participants are either contacted by the German Childhood Cancer Registry (GCCR), transitioned from the local pediatric oncology care unit, or recruited via media. They are assigned to one of three different risk groups based on an evidence-based risk stratification and receive standardized multidisciplinary follow-up care. Primary outcomes are satisfaction with the LTFU care offer as well as degree of health-related self-efficacy expectation. They will be assessed at two time points. A scientific evaluation of the implemented LTFU care will be enabled by a waitlist control group. The harmonized outcome data are documented in a standardized database.
By addressing CCS in Germany who have not received standardized LTFU care yet, the LE-Na study expects to improve nationwide LTFU care and therewith patient's satisfaction with the LTFU care offer as well as their health-related self-efficacy expectation.
癌症治疗数年至数十年后可能出现远期效应，导致发病并降低与健康相关的生活质量。临床长期随访（LTFU）能够及时诊断和治疗这些后遗症。到目前为止，德国只有少数儿童癌症幸存者（CCS）定期前往长期随访护理机构就诊。LE-Na研究旨在：1. 实施和/或改善德国成年CCS的长期随访护理结构；2. 告知既往患者远期效应及长期随访护理中心的情况；3. 通过建立中央数据库、同意管理和基础设施，为未来研究奠定基础；4. 在德国建立成年CCS的临床长期随访队列；5. 评估长期随访护理的实施情况；6. 推动长期随访护理结构在全国范围内的扩展；7. 将已建立的长期随访护理结构纳入标准医疗保健系统。
在五年内，约5000名CCS将被邀请前往德国的10个长期随访中心之一就诊。研究参与者要么由德国儿童癌症登记处（GCCR）联系，要么从当地儿科肿瘤护理单位转诊，要么通过媒体招募。根据循证风险分层，他们被分配到三个不同风险组之一，并接受标准化的多学科随访护理。主要结局是对长期随访护理服务的满意度以及与健康相关的自我效能期望程度。将在两个时间点进行评估。通过一个候补对照组对实施的长期随访护理进行科学评估。统一的结局数据记录在标准化数据库中。
通过关注德国尚未接受标准化长期随访护理的CCS，LE-Na研究期望改善全国范围内的长期随访护理，从而提高患者对长期随访护理服务的满意度以及他们与健康相关的自我效能期望。
