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Comprehensive assessments and related interventions to enhance the long-term outcomes of child, adolescent and young adult cancer survivors - presentation of the CARE for CAYA-Program study protocol and associated literature review.
Salchow, J; Mann, J; Koch, B; von Grundherr, J; Jensen, W; Elmers, S; Straub, L A; Vettorazzi, E; Escherich, G; Rutkowski, S; Dwinger, S; Bergelt, C; Sokalska-Duhme, M; Bielack, S; Calaminus, G; Baust, K; Classen, C F; Rössig, C; Faber, J; Faller, H; Hilgendorf, I; Gebauer, J; Langer, T; Metzler, M; Schuster, S; Niemeyer, C; Puzik, A; Reinhardt, D; Dirksen, U; Sander, A; Köhler, M; Habermann, J K; Bokemeyer, C; Stein, A.
Afiliación
  • Salchow J; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. j.salchow@uke.de.
  • Mann J; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Koch B; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • von Grundherr J; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Jensen W; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Elmers S; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Straub LA; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Vettorazzi E; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Escherich G; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Rutkowski S; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Dwinger S; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Bergelt C; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Sokalska-Duhme M; Klinikum Stuttgart, Olgahospital, Stuttgart, Germany.
  • Bielack S; Klinikum Stuttgart, Olgahospital, Stuttgart, Germany.
  • Calaminus G; University Hospital Bonn, Bonn, Germany.
  • Baust K; University Hospital Bonn, Bonn, Germany.
  • Classen CF; University Hospital Rostock, Rostock, Germany.
  • Rössig C; University Children's Hospital Münster, Münster, Germany.
  • Faber J; Mainz University Medical Center, Mainz, Germany.
  • Faller H; University Hospital Würzburg, Würzburg, Germany.
  • Hilgendorf I; University Hospital Jena, Jena, Germany.
  • Gebauer J; University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
  • Langer T; University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
  • Metzler M; University Hospital Erlangen, Erlangen, Germany.
  • Schuster S; University Hospital Erlangen, Erlangen, Germany.
  • Niemeyer C; Medical Centre, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Puzik A; Medical Centre, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Reinhardt D; University Hospital Essen, Essen, Germany.
  • Dirksen U; German Cancer Consortium, Essen, Germany.
  • Sander A; University Hospital Essen, Essen, Germany.
  • Köhler M; German Cancer Consortium, Essen, Germany.
  • Habermann JK; Hannover Medical School, Hannover, Germany.
  • Bokemeyer C; Medical Faculty University Hospital Magdeburg, Magdeburg, Germany.
  • Stein A; University of Lübeck, Lübeck, Germany.
BMC Cancer ; 20(1): 16, 2020 Jan 06.
Article en En | MEDLINE | ID: mdl-31906955
BACKGROUND: Improved, multimodal treatment strategies have been shown to increase cure rates in cancer patients. Those who survive cancer as a child, adolescent or young adult (CAYA), are at a higher risk for therapy-, or disease-related, late or long-term effects. The CARE for CAYA-Program has been developed to comprehensively assess any potential future problems, to offer need-based preventative interventions and thus to improve long-term outcomes in this particularly vulnerable population. METHODS: The trial is designed as an adaptive trial with an annual comprehensive assessment followed by needs stratified, modular interventions, currently including physical activity, nutrition and psycho-oncology, all aimed at improving the lifestyle and/or the psychosocial situation of the patients. Patients, aged 15-39 years old, with a prior cancer diagnosis, who have completed tumour therapy and are in follow-up care, and who are tumour free, will be included. At baseline (and subsequently on an annual basis) the current medical and psychosocial situation and lifestyle of the participants will be assessed using a survey compiled of various validated questionnaires (e.g. EORTC QLQ C30, NCCN distress thermometer, PHQ-4, BSA, nutrition protocol) and objective parameters (e.g. BMI, WHR, co-morbidities like hyperlipidaemia, hypertension, diabetes), followed by basic care (psychological and lifestyle consultation). Depending on their needs, CAYAs will be allocated to preventative interventions in the above-mentioned modules over a 12-month period. After 1 year, the assessment will be repeated, and further interventions may be applied as needed. During the initial trial phase, the efficacy of this approach will be compared to standard care (waiting list with intervention in the following year) in a randomized study. During this phase, 530 CAYAs will be included and 320 eligible CAYAs who are willing to participate in the interventions will be randomly allocated to an intervention. Overall, 1500 CAYAs will be included and assessed. The programme is financed by the innovation fund of the German Federal Joint Committee and will be conducted at 14 German sites. Recruitment began in January 2018. DISCUSSION: CAYAs are at high risk for long-term sequelae. Providing structured interventions to improve lifestyle and psychological situation may counteract against these risk factors. The programme serves to establish uniform regular comprehensive assessments and need-based interventions to improve long-term outcome in CAYA survivors. TRIAL REGISTRATION: Registered at the German Clinical Trial Register (ID: DRKS00012504, registration date: 19th January 2018).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cuidados Posteriores / Supervivientes de Cáncer Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Prognostic_studies / Qualitative_research / Risk_factors_studies Límite: Adolescent / Adult / Child / Female / Humans / Male Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2020 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cuidados Posteriores / Supervivientes de Cáncer Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Prognostic_studies / Qualitative_research / Risk_factors_studies Límite: Adolescent / Adult / Child / Female / Humans / Male Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2020 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido