Effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors: protocol of the multicenter, randomized-controlled AELKI study
Hannah Schmidt,
Katja Baust,
Gabriele Calaminus,
Lisa Hohls,
Katharina Tetzner,
Nicole Griech,
Henrike Haugke,
Hannah Baltus,
Susanne Elsner,
Alexander Katalinic,
Hera Becker,
Chirine Cytera,
Judith Gebauer,
Ann-Kristin Kock-Schoppenhauer,
Anke Neumann,
Christian Denzer,
Michael M. Schündeln,
Jörg Faber,
Conny Sattler,
Michael C. Frühwald,
Anja Borgmann-Staudt,
Anke Barnbrock,
Markus Metzler,
Gabriele Escherich,
Inke R. König,
Ingo Menrath,
Thorsten Langer
Affiliations
Hannah Schmidt
Clinic for Pediatric and Adolescent Medicine, University Hospital Schleswig-Holstein
Katja Baust
Center for Pediatrics, Bonn University Hospital
Gabriele Calaminus
Center for Pediatrics, Bonn University Hospital
Lisa Hohls
Clinic for Pediatric and Adolescent Medicine, University Hospital Schleswig-Holstein
Katharina Tetzner
Center for Pediatrics, Bonn University Hospital
Nicole Griech
Center for Pediatrics, Bonn University Hospital
Henrike Haugke
Center for Pediatrics, Bonn University Hospital
Hannah Baltus
Institute for Social Medicine and Epidemiology, University of Lübeck
Susanne Elsner
Institute for Social Medicine and Epidemiology, University of Lübeck
Alexander Katalinic
Institute for Social Medicine and Epidemiology, University of Lübeck
Hera Becker
Clinic for Pediatric and Adolescent Medicine, University Hospital Schleswig-Holstein
Chirine Cytera
Clinic for Pediatric and Adolescent Medicine, University Hospital Schleswig-Holstein
Judith Gebauer
Department of Internal Medicine 1, University Hospital Schleswig-Holstein
Ann-Kristin Kock-Schoppenhauer
IT Center for Clinical Research, University of Lübeck
Anke Neumann
IT Center for Clinical Research, University of Lübeck
Christian Denzer
Department of Pediatrics and Adolescent Medicine, Section of Pediatric Endocrinology and Diabetology Hormone Center for Children and Adolescents, Ulm University Hospital
Michael M. Schündeln
Division of Pediatric Hematology and Oncology, Department of Pediatrics III, University Hospital Essen, University of Duisburg-Essen
Jörg Faber
Center for Pediatric and Adolescent Medicine, University Medical Center of Johannes Gutenberg University Mainz
Conny Sattler
Clinic for Pediatric and Adolescent Medicine, University Medical Center Schleswig-Holstein
Michael C. Frühwald
Pediatrics and Adolescent Medicine, University Medical Center Augsburg, Swabian Children’s Cancer Center
Anja Borgmann-Staudt
Department of Pediatrics With Focus On Oncology/Hematology, Charité Medical Center Berlin
Anke Barnbrock
Department of Pediatrics, Division of Hematology, Oncology and Hemostaseology, Goethe University
Markus Metzler
Clinic for Pediatrics and Adolescent Medicine, University Hospital Erlangen
Gabriele Escherich
Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf
Inke R. König
Institute of Medical Biometry and Statistics, University of Lübeck
Ingo Menrath
Clinic for Pediatric and Adolescent Medicine, University Hospital Schleswig-Holstein
Thorsten Langer
Clinic for Pediatric and Adolescent Medicine, University Hospital Schleswig-Holstein
Abstract Background In Germany, around 2.250 children and adolescents are diagnosed with cancer each year. Despite generally positive long-term survival rates, many patients must cope with late effects of the disease and its treatment. This highlights the need for a well-structured, long-term approach addressing both physical and mental health issues. Currently, the German healthcare system lacks such comprehensive structures. Our study aims to evaluate the effectiveness of a structured, multidisciplinary long-term approach compared to conventional “treatment as usual” (TAU). Methods A prospective, multicenter study with ten pediatric university clinics in Germany will be conducted. The cluster-randomization takes place at the clinic level. Children and adolescents who completed their cancer treatment at least five years ago and their parents will be eligible to participate. While the control group (CG) receives TAU, the intervention group (IG) participates in a structured program. This program includes risk-based medical treatment and psychosocial interventions tailored to each patient’s individual needs within a two-month timeframe. The primary outcome is the improvement of self-efficacy. Secondary outcomes are satisfaction with health care, improvement of health-related quality of life (HRQoL), reduction of mental health problems, and improvement of transition readiness. Discussion This approach has the potential to optimize the health care for individuals who survived cancer during childhood or adolescence. It addresses the challenges of overuse, underuse, and misuse of health care resources. By considering both medical and psychosocial factors and promoting increased self-efficacy, independent from parental involvement, it may facilitate a smoother transition to adult medicine and enhance adherence to lifelong aftercare. If proven successful, this approach will contribute to the integration of multidisciplinary strategies into standard healthcare practice. Trial registration German Clinical Trials Register DRKS00029269. Registered on December 23, 2022.
