Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors (NCT04287218) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors
Denmark200 participantsStarted 2023-05-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline to 2nd follow-up