Study protocol of the CORRECT multicenter trial: the efficacy of blended cognitive behavioral therapy for reducing psychological distress in colorectal cancer survivors
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Le résumé fourni par la source
BACKGROUND: Approximately one third of the colorectal cancer survivors (CRCS) experience high levels of psychological distress. Common concerns experienced by CRCS include distress related to physical problems, anxiety, fear of cancer recurrence (FCR) and depressive symptoms. However, psychological interventions for distressed CRCS are scarce. Therefore, a blended therapy was developed, combining face-to-face cognitive behavioral therapy (CBT) with online self-management activities and telephone consultations. The aim of the study is to evaluate the efficacy and cost-effectiveness of this blended therapy in reducing psychological distress in CRCS. METHODS/DESIGN: The CORRECT study is a two-arm multicenter randomized controlled trial (RCT). A sample of 160 highly distressed CRCS (a score on the Distress Thermometer of 5 or higher) will be recruited from several hospitals in the Netherlands. CRCS will be randomized to either the intervention condition (blended CBT) or the control condition (care as usual). The blended therapy covers approximately 14 weeks and combines five face-to-face sessions and three telephone consultations with a psychologist, with access to an interactive self-management website. It includes three modules which are individually-tailored to patient concerns and aimed at decreasing: 1) distress caused by physical consequences of CRC, 2) anxiety and FCR, 3) depressive symptoms. Patients can choose between the optional modules. The primary outcome is general distress (Brief Symptom Inventory-18). Secondary outcomes are quality of life and general psychological wellbeing. Assessments will take place at baseline prior to randomization, after 4 and 7 months. DISCUSSION: Blended CBT is an innovative and promising approach for providing tailored supportive care to reduce high distress in CRCS. If the intervention proves to be effective, an evidence-based intervention will become available for implementation in clinical practice. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register ( NTR6025 ) on August 3, 2016.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Study protocol of the CORRECT multicenter trial: the efficacy of blended cognitive behavioral therapy for reducing psychological distress in colorectal cancer survivors
- Date Crossref
- 18/07/2018
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Radboud University Nijmegen pays non établi dans la noticeUniversité ou école supérieure
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Radboud University Medical Center Radboud Institute for Health Sciences pays non établi dans la noticeOrganisme public
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Radboud Institute for Molecular Life Sciences pays non établi dans la noticeStructure de recherche
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Amsterdam University Medical Centers pays non établi dans la noticeÉtablissement de santé
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AMN (Netherlands) pays non établi dans la noticeEntreprise
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Amsterdam Neuroscience pays non établi dans la noticeStructure de recherche
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Amsterdam UMC Location Vrije Universiteit Amsterdam pays non établi dans la noticeÉtablissement de santé
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Department of Medical Psychology pays non établi dans la noticeInstitution
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Siza (disability service) Arnhem pays non établi dans la noticeInstitution
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Department of Psychiatry pays non établi dans la noticeInstitution
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Department of Rehabilitation Medicine pays non établi dans la noticeInstitution
Radboud University Nijmegen, Radboud Institute for Health Sciences — Radboud University Medical Center et Radboud Institute for Molecular Life Sciences, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.