Study protocol of the CORRECT multicenter trial: the efficacy of blended cognitive behavioral therapy for reducing psychological distress in colorectal cancer survivors

被引：15

作者：

Leermakers, L. ^{[1
]}

Doking, S. ^{[1
]}

Thewes, B. ^{[1
]}

Braamse, A. M. J. ^{[2
]}

Gielissen, M. F. M. ^{[3
,4
]}

de Wilt, J. H. W. ^{[5
]}

Collette, E. H. ^{[6
]}

Dekker, J. ^{[7
,8
]}

Prins, J. B. ^{[1
]}

机构：

[1] Radboud Univ Nijmegen Med Ctr, Dept Med Psychol, Radboud Inst Hlth Sci, 840,POB 9101, NL-6500 HB Nijmegen, Netherlands

[2] Amsterdam UMC, Dept Med Psychol, POB 22660, NL-1100 DD Amsterdam, Netherlands

[3] Radboud Univ Nijmegen Med Ctr, Radboud Inst Hlth Sci, Dept Primary & Community Care, POB 9101, NL-6500 HB Nijmegen, Netherlands

[4] Siza Disabil Serv Arnhem, POB 532, NL-6800 AM Arnhem, Netherlands

[5] Radboud Univ Nijmegen Med Ctr, Radboud Inst Hlth Sci, Dept Surg, 725,POB 9101, NL-6500 HB Nijmegen, Netherlands

[6] Amsterdam UMC, Dept Med Psychol, POB 7057, NL-1007 MB Amsterdam, Netherlands

[7] Amsterdam UMC, Dept Rehabil Med, POB 7057, NL-1007 MB Amsterdam, Netherlands

[8] Amsterdam UMC, Dept Psychiat, POB 7057, NL-1007 MB Amsterdam, Netherlands

来源：

BMC CANCER | 2018年 / 18卷

关键词：

Colorectal cancer survivors; Psychological distress; Blended therapy; Cognitive behavior therapy; Quality of life; Randomized controlled trial; QUALITY-OF-LIFE; RANDOMIZED CONTROLLED-TRIAL; PSYCHOSOCIAL INTERVENTIONS; HOSPITAL ANXIETY; DEPRESSION SCALE; CHRONIC-FATIGUE; EVENT SCALE; FEAR; RECURRENCE; BREAST;

D O I：

10.1186/s12885-018-4645-6

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页数：12

共 89 条

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