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The CORRECT-study


- candidate number24725
- NTR NumberNTR6025
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-aug-2016
- Secondary IDs2015-2077 NL55018.091.15 CMO Arnhem-Nijmegen
- Public TitleThe CORRECT-study
- Scientific TitleEffectiveness of blended therapy for reducing psychological distress in colorectal cancer survivors: the CORRECT multicenter trial
- ACRONYMThe CORRECT-study
- hypothesis
- Healt Condition(s) or Problem(s) studiedColorectal cancer, E-health, Cognitive behavior therapy
- Inclusion criteria- Colorectal cancer treated with curative intent (stage l, ll and lll)
- Completed cancer treatment at least 6 months and no more than 5 years
- Cancer-free at study-entry
- 18 years or older
- Distress Thermometer score of 5 or higher
- Sufficient comprehension of the Dutch language to fill out questionnaires
- Basic internet skills (e.g. possession of email address, internet access at home, weekly internet use and able to use internet without help of others)
- Able to travel to the hospital for the CBT intervention
- Exclusion criteria- No current psychological treatment or during the last month
- lnability to provide informed consent due to intellectual disability or cognitive impairment
- Diagnosis of Lynch Syndrome
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2018
- Target number of participants160
- InterventionsThe intervention is based on cognitive behavior therapy (CBT) and consists of blended therapy, a combination of face-to-face CBT with a self-management interactive website. The intervention lasts four months and compromises of five individual face-to-face sessions, supplemented by three telephone contacts. Patients will have daily access to the self-management website. The CBT protocol is directed at changing cognitions and behavior related to distress. Treatment will be individually-tailored based on the presenting problems identified during clinical assessment and and the data gathered during baseline assessment. The intervention consists of one generic module and three optional modules. Three different types of distress will be addressed in the modules: 1) distress caused by physical consequences (e.g. post-cancer fatigue, gastrointestinal problems, urinary incontinence and sexual dysfunction), 2) anxiety and fear of recurrence, 3) depressive mood.
- Primary outcomePsychological distress as measured by the Brief Symptom Inventory (BSI-18)
- Secondary outcomeGeneral quality of life (EORTC-QLQ-C30), supplemented by a disease specific module quality of life module: (EORTC QLQ-CR38), Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS), Fear of cancer recurrence (Cancer Worry Scale, CWS), Fatigue (Checklist Individual Strength, CIS).
- TimepointsPatients will be asked to complete questionnaires at three different time points; baseline (T0, before randomization), 4 months (T1) and 7 months (T2) after randomization.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lynn Leermakers
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.B. Prins
- Sponsor/Initiator Radboud University Medical Center Nijmegen, VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- Publications
- Brief summaryUp to 35% of colorectal cancer survivors (CRCS) experience high levels of psychological distress. Interventions for distressed CRCS are scarce. Therefore, we developed a blended therapy, combining face-to-face cognitive behavioral therapy (CBT) with online self-management activities. This enables patients to complete part of their treatment at home at their convenience and spend more time learning and practicing CBT skills to manage distress. The intervention consists of one generic module and three optional modules which are aimed at decreasing: 1) distress caused by physical consequences, 2) anxiety and fear of recurrence, 3) depressive mood. The intervention will be tailored to patientsí individual needs.
In a two-arm randomized controlled trial the efficacy of blended care will be compared to treatment as usual in reducing psychological distress and improving quality of life. Treatment will be compared with a usual care control condition. The primary outcome is general distress. The efficacy of the intervention is evaluated in a randomized controlled trial carried out in the Netherlands.
- Main changes (audit trail)
- RECORD3-aug-2016 - 16-okt-2016


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