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
{"title":"为小儿癌症幸存者提供结构化、多学科长期护理的有效性：多中心、随机对照 AELKI 研究方案。","authors":"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","doi":"10.1186/s13063-024-08377-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00029269. Registered on December 23, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11382442/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors: protocol of the multicenter, randomized-controlled AELKI study.\",\"authors\":\"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\",\"doi\":\"10.1186/s13063-024-08377-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00029269. 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Effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors: protocol of the multicenter, randomized-controlled AELKI study.
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.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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