Clinical trial · Interventional
Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors
A Randomized Controlled Trial Comparing the Efficacy of Therapist Guided Internet-delivered Cognitive Therapy (TG-iConquerFear) With Augmented Treatment as Usual in Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors
NCT04287218CI-TRIAL-00123319completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Bodily Distress Syndrome | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
| Health Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aTAU | Behavioral | — | UNRESOLVED |
| TG-iConquerFear | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TG-iConquerFear
- description
- The participant is guided through the web-based sessions by minimum weekly contact with an experienced therapist (estimated ½ hour/week for 10 weeks). The therapist will motivate, answer questions and give feedback on written material and exercises.
- interventionNames
- Behavioral: TG-iConquerFear
- type
- ACTIVE_COMPARATOR
- label
- Augmented treatment as usual
- description
- The control group is described as "augmented" treatment as usual (aTAU), since the diagnostic telephone interview exceeds standard treatment. Further more, the participants will be referred to a website with a non-guided, publicly available E-learning program in cancer rehabilitation hosted by the Region of Central Jutland (livogkraeft.rm.dk). In addition to written material the website includes self-help instructions for meditation.
- interventionNames
- Behavioral: aTAU
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Completed curative intent colorectal cancer treatment with surgery and/or radiation and/or adjuvant chemotherapy between 1 March 2014 and 31 December 2018 * No history of recurrence after primary operation * Fear of Cancer Recurrence Inventory score of 22 or above (14) * Age 18 or above * Reads and understands Danish * Access and ability to use Internet Exclusion Criteria: * Cancer recurrence at any follow-up * Inability to comply with the protocol due to severe psychiatric, cognitive disorder or substance abuse identified during telephone interview * As the intervention is web-based, participants without knowledge of or access to the Internet will be excluded from the RCT (including dyslexia).
References
Publications (68)
- BACKGROUNDJefford M, Ward AC, Lisy K, Lacey K, Emery JD, Glaser AW, Cross H, Krishnasamy M, McLachlan SA, Bishop J. Patient-reported outcomes in cancer survivors: a population-wide cross-sectional study. Support Care Cancer. 2017 Oct;25(10):3171-3179. doi: 10.1007/s00520-017-3725-5. Epub 2017 Apr 22. PMID 28434095
- BACKGROUNDSimard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10. PMID 23475398
- BACKGROUNDLebel S, Ozakinci G, Humphris G, Mutsaers B, Thewes B, Prins J, Dinkel A, Butow P; University of Ottawa Fear of Cancer Recurrence Colloquium attendees. From normal response to clinical problem: definition and clinical features of fear of cancer recurrence. Support Care Cancer. 2016 Aug;24(8):3265-8. doi: 10.1007/s00520-016-3272-5. Epub 2016 May 12. PMID 27169703
- BACKGROUNDvan de Wal M, van de Poll-Franse L, Prins J, Gielissen M. Does fear of cancer recurrence differ between cancer types? A study from the population-based PROFILES registry. Psychooncology. 2016 Jul;25(7):772-8. doi: 10.1002/pon.4002. Epub 2015 Oct 14. PMID 26464337
- BACKGROUNDKoch L, Jansen L, Brenner H, Arndt V. Fear of recurrence and disease progression in long-term (>/= 5 years) cancer survivors--a systematic review of quantitative studies. Psychooncology. 2013 Jan;22(1):1-11. doi: 10.1002/pon.3022. Epub 2012 Jan 10. PMID 22232030
- BACKGROUNDMcGinty HL, Small BJ, Laronga C, Jacobsen PB. Predictors and patterns of fear of cancer recurrence in breast cancer survivors. Health Psychol. 2016 Jan;35(1):1-9. doi: 10.1037/hea0000238. Epub 2015 Jun 1. PMID 26030308
- BACKGROUNDDeimling GT, Bowman KF, Sterns S, Wagner LJ, Kahana B. Cancer-related health worries and psychological distress among older adult, long-term cancer survivors. Psychooncology. 2006 Apr;15(4):306-20. doi: 10.1002/pon.955.