Johanne Dam Lyhne1, Allan ' Ben' Smith2, Lisbeth Frostholm3, Per Fink3, Lars Henrik Jensen4. 1. Department of Clinical Oncology, University Hospital of Southern Denmark, Vejle, Beriderbakken 4, 7100, Vejle, Denmark. Johanne.Dam.Lyhne@rsyd.dk. 2. Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, 2170, Australia. 3. Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Nørrebrogade 44, bygn. 4, 1, 8000, Aarhus C, Denmark. 4. Department of Clinical Oncology, University Hospital of Southern Denmark, Vejle, Beriderbakken 4, 7100, Vejle, Denmark.
Abstract
BACKGROUND:Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors. METHODS/ DESIGN: A population-based randomized controlled trial (RCT) comparing TG-iConquerFear with aTAU (1:1) in n = 246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) ≥ 22 and semi-structured interview). Evaluation will be conducted at 2 weeks, 3 and 6 months post-treatment and between-group differences will be evaluated. Long-term effects will be evaluated after one year. Primary outcome will be post-treatment FCR (FCRI-SF). Secondary outcomes are global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data). Explanatory outcomes include: Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100). DISCUSSION: This RCT will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. aTAU for CRC survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.
RCT Entities:
BACKGROUND: Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors. METHODS/ DESIGN: A population-based randomized controlled trial (RCT) comparing TG-iConquerFear with aTAU (1:1) in n = 246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) ≥ 22 and semi-structured interview). Evaluation will be conducted at 2 weeks, 3 and 6 months post-treatment and between-group differences will be evaluated. Long-term effects will be evaluated after one year. Primary outcome will be post-treatment FCR (FCRI-SF). Secondary outcomes are global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data). Explanatory outcomes include: Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100). DISCUSSION: This RCT will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. aTAU for CRC survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.
Entities:
Keywords:
Anxiety; Cognitive therapy; Colorectal cancer; Digital health; Fear of cancer recurrence; Internet-based; Randomized controlled trial
Authors: Fiona A Lynch; Lynda Katona; Michael Jefford; Allan Ben Smith; Joanne Shaw; Haryana M Dhillon; Steve Ellen; Jo Phipps-Nelson; Julia Lai-Kwon; Donna Milne; Lahiru Russell; Victoria Dax; Justine Diggens; Holly Kent; Alison Button-Sloan; Jane Elliott; Mark Shackleton; Hayley Burridge; Maria Ftanou Journal: J Clin Med Date: 2020-09-14 Impact factor: 4.241