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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
Sponsor:
Collaborators:
Research Clinic for Functional Disorders, Aarhus University Hospital
Centre for Oncology Education and Research Translation (CONCERT), Australia
Danish Cancer Society
Information provided by (Responsible Party):
Vejle Hospital

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TG-iConquerFear
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
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.
Behavioral: aTAU
Active control group
Other Name: Augmented treatment as usual




Primary Outcome Measures :
  1. Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline to 2nd follow-up [ Time Frame: 3 months post-intervention ]
    Questionnaire


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Evaluation of cost-effectiveness of TG-iConquerFear [ Time Frame: Max. 27 months ]
    Information will be extracted from Danish registries.

  6. Comparison of changes in health care usage between intervention arm and aTAU [ Time Frame: Max. 27 months ]
    Information will be extracted from Danish registries.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Johanne Lyhne, MD +45 7940 5000 Johanne.Dam.Lyhne@rsyd.dk
Contact: Research secretary karin.larsen1@rsyd.dk

Sponsors and Collaborators
Vejle Hospital
Research Clinic for Functional Disorders, Aarhus University Hospital
Centre for Oncology Education and Research Translation (CONCERT), Australia
Danish Cancer Society
Investigators
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Study Chair: Lars Henrik Jensen, MD, PhD Vejle Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT04287218    
Other Study ID Numbers: TG-iConquerFear
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available up on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vejle Hospital:
internet-based
digital health
cognitive therapy
randomized controlled trial
Additional relevant MeSH terms:
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Colorectal Neoplasms
Recurrence
Anxiety Disorders
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Mental Disorders
Disease Attributes
Pathologic Processes