Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors

NCT04287218 | Active Not Recruiting

• 1 other identifier: TG-iConquerFear
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fear of Cancer Recurrence; Colorectal Cancer; Anxiety; Health Anxiety; Bodily Distress Syndrome

Keywords

internet-based; digital health; cognitive therapy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline to 2nd follow-up

  Questionnaire

  3 months post-intervention

Secondary Outcomes (6)

• Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline

  1-14 days after intervention and after 6 and 12 months

• Change in Bodily Distress Syndrome from baseline as evaluated by the BDS Checklist

  1-14 days after intervention and after 6 and 12 months

• Change in anxiety and depression from baseline as evaluated by the relevant Symptom Checklist-90-R

  1-14 days after intervention and after 6 and 12 months

• Change in health anxiety from baseline as measured by the Whiteley-6 index

  1-14 days after intervention and after 6 and 12 months

• Evaluation of cost-effectiveness of TG-iConquerFear

  Max. 27 months

Other Outcomes (3)

• Change in uncertainty in illness as evaluated by Mishels Uncertainty of Illness Scale (MUIS).

  Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months

• Change of negative beliefs about worry evaluated by MetaCognitions Questionnaire-30.

  Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months

• Perceived risk of recurrence measured by the visual analogue scale from 1-100

  Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months

Study Arms (2)

TG-iConquerFear

EXPERIMENTAL

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.

Behavioral: TG-iConquerFear

Augmented treatment as usual

ACTIVE COMPARATOR

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.

Behavioral: aTAU

Interventions

TG-iConquerFear BEHAVIORAL

The theoretical frame of iConquerFear is based on the Common-Sense Model of illness, the Self-Regulatory Executive Function model and Relational Frame Theory. The intervention includes elements of attention training, increasing metacognitive awareness, acceptance \& mindfulness, promotion of appropriate screening behavior, and values-based goal setting. The electronic platform comprises 5 modules containing educational text, interactive exercises, short videos featuring doctors, therapists and patients' perspectives.

TG-iConquerFear

aTAU BEHAVIORAL

Active control group

Also known as: Augmented treatment as usual

Augmented treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vejle Hospital: lead
• Aarhus University Hospital: collaborator
• Centre for Oncology Education and Research Translation (CONCERT), Australia: collaborator
• Danish Cancer Society: collaborator

Study Sites (1)

Vejle Hospital, University Hospital of Southern Denmark

Vejle, 7100, Denmark

Location

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• Lyhne JD, Smith AB, Timm S, Klein B, Thewes B, Girgis A, Bamgboje-Ayodele A, Beatty L, Fardell J, Fink P, Butow P, Frostholm L, Jensen LH. E-Health Intervention for Fear of Cancer Recurrence: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2542112. doi: 10.1001/jamanetworkopen.2025.42112.

  PMID: 41217757 DERIVED

• Lyhne JD, Smith A'B, Frostholm L, Fink P, Jensen LH. Study protocol: 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. BMC Cancer. 2020 Mar 16;20(1):223. doi: 10.1186/s12885-020-06731-6.

  PMID: 32178640 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mental Disorders

Study Officials

• Lars Henrik Jensen, MD, PhD

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Survey: The study is population based and cross sectional. Participants will be invited to complete an electronic questionnaire to screen for fear of cancer recurrence and other psychological factors. RCT: This part of the study is a population based, randomized, controlled clinical superiority trial. Participants are randomized to internet-based, therapist guided iConquerFear or augmented treatment as usual (1:1). If the planned number of participants (estimated by power calculation) has not been enrolled through the scheduled screening process, colorectal cancer survivors diagnosed during 2019 will be invited to the screening, and if needed, also colorectal cancer survivors diagnosed in 2020. The additional screening invitations will be sent out immediately after the last round of screening, i.e. before any follow-up data have been obtained. Hence, the statistical analyses will not be affected in any way.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: May 10, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)