Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT04287218|
Recruitment Status : Not yet recruiting
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fear of Cancer Recurrence Colorectal Cancer Anxiety Health Anxiety Bodily Distress Syndrome||Behavioral: TG-iConquerFear Behavioral: aTAU||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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).
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||May 2024|
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.
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.
Active Comparator: Augmented treatment as usual
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.
Active control group
Other Name: Augmented treatment as usual
- Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline to 2nd follow-up [ Time Frame: 3 months post-intervention ]Questionnaire
- Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline [ Time Frame: 1-14 days after intervention and after 6 and 12 months ]Questionnaire
- Change in Bodily Distress Syndrome from baseline as evaluated by the BDS Checklist [ Time Frame: 1-14 days after intervention and after 6 and 12 months ]Questionnaire
- Change in anxiety and depression from baseline as evaluated by the relevant Symptom Checklist-90-R [ Time Frame: 1-14 days after intervention and after 6 and 12 months ]Questionnaire
- Change in health anxiety from baseline as measured by the Whiteley-6 index [ Time Frame: 1-14 days after intervention and after 6 and 12 months ]Questionnaire
- Evaluation of cost-effectiveness of TG-iConquerFear [ Time Frame: Max. 27 months ]Information will be extracted from Danish registries.
- Comparison of changes in health care usage between intervention arm and aTAU [ Time Frame: Max. 27 months ]Information will be extracted from Danish registries.
- Change in uncertainty in illness as evaluated by Mishels Uncertainty of Illness Scale (MUIS). [ Time Frame: Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months ]Process measures. Questionnaire
- Change of negative beliefs about worry evaluated by MetaCognitions Questionnaire-30. [ Time Frame: Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months ]Process measures. Questionnaire
- Perceived risk of recurrence measured by the visual analogue scale from 1-100 [ Time Frame: Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months ]Process measures. Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287218
|Contact: Johanne Lyhne, MD||+45 7940 5000||Johanne.Dam.Lyhne@rsyd.dk|
|Contact: Research email@example.com|
|Study Chair:||Lars Henrik Jensen, MD, PhD||Vejle Hospital|