Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT04287218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nRCT: 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).\n\nIf 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.\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in uncertainty in illness as evaluated by Mishels Uncertainty of Illness Scale (MUIS).', 'timeFrame': 'Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months', 'description': 'Process measures. Questionnaire'}, {'measure': 'Change of negative beliefs about worry evaluated by MetaCognitions Questionnaire-30.', 'timeFrame': 'Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months', 'description': 'Process measures. Questionnaire'}, {'measure': 'Perceived risk of recurrence measured by the visual analogue scale from 1-100', 'timeFrame': 'Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months', 'description': 'Process measures. Scale.'}], 'primaryOutcomes': [{'measure': 'Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline to 2nd follow-up', 'timeFrame': '3 months post-intervention', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline', 'timeFrame': '1-14 days after intervention and after 6 and 12 months', 'description': 'Questionnaire'}, {'measure': 'Change in Bodily Distress Syndrome from baseline as evaluated by the BDS Checklist', 'timeFrame': '1-14 days after intervention and after 6 and 12 months', 'description': 'Questionnaire'}, {'measure': 'Change in anxiety and depression from baseline as evaluated by the relevant Symptom Checklist-90-R', 'timeFrame': '1-14 days after intervention and after 6 and 12 months', 'description': 'Questionnaire'}, {'measure': 'Change in health anxiety from baseline as measured by the Whiteley-6 index', 'timeFrame': '1-14 days after intervention and after 6 and 12 months', 'description': 'Questionnaire'}, {'measure': 'Evaluation of cost-effectiveness of TG-iConquerFear', 'timeFrame': 'Max. 27 months', 'description': 'Information will be extracted from Danish registries.'}, {'measure': 'Comparison of changes in health care usage between intervention arm and aTAU', 'timeFrame': 'Max. 27 months', 'description': 'Information will be extracted from Danish registries.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['internet-based', 'digital health', 'cognitive therapy', 'randomized controlled trial'], 'conditions': ['Fear of Cancer Recurrence', 'Colorectal Cancer', 'Anxiety', 'Health Anxiety', 'Bodily Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '28434095', 'type': 'BACKGROUND', 'citation': 'Jefford M, Ward AC, Lisy K, Lacey K, Emery JD, Glaser AW, Cross H, Krishnasamy M, McLachlan SA, Bishop J. 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Epub 2014 Dec 20.'}, {'pmid': '14998733', 'type': 'BACKGROUND', 'citation': 'Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. doi: 10.1016/S0005-7967(03)00147-5.'}, {'pmid': '9220301', 'type': 'BACKGROUND', 'citation': 'Cartwright-Hatton S, Wells A. Beliefs about worry and intrusions: the Meta-Cognitions Questionnaire and its correlates. J Anxiety Disord. 1997 May-Jun;11(3):279-96. doi: 10.1016/s0887-6185(97)00011-x.'}, {'pmid': '41217757', 'type': 'DERIVED', 'citation': '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': '32178640', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Colorectal cancer (CRC) screening, early detection, and improved treatment have led to rising survival rates over the past decades. This improvement has resulted in an increasing number of long-term CRC survivors with no residual disease. Most survivors manage to establish a \'new normal\' after finishing treatment, but some survivors experience difficulties in normal functioning and decreased quality of life (QoL) due to substantial psychological strain. Anxiety and depression e.g. are reported in 34% of CRC survivors 1-5 years post-diagnosis. One of the most common concerns among cancer survivors is fear of cancer recurrence (FCR), defined as "Fear, worry or concern relating to the possibility that cancer will come back or progress". The severity of self-reported FCR does not seem to differ much according to cancer type and FCR can persist even among very long term survivors. Higher FCR is associated with multiple psychological factors including (health) anxiety, depression, greater uncertainty in illness, perceived risk of recurrence and negative beliefs about worry. An expert consensus on the defining features of clinical FCR suggested, that the following four features are key characteristics of clinical FCR: a) high levels of preoccupation; b) high levels of worry; c) that are persistent; and d) hypervigilance to bodily symptom.\n\nMost CRC survivors report some degree of FCR. The term "clinically significant FCR" is introduced to describe when the strain of FCR becomes clinically important, negatively influencing the life of the survivor. Validated screening questionnaires, such as the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), have been used to identify likely cases of clinically significant FCR. Two recent studies report likely clinically significant FCR based on the FCRI-SF among 13,7% and 10,1% of CRC survivors (unpublished data, personal communication with first authors). However, the prevalence of clinical FCR in CRC survivors is still somewhat uncertain, as estimates are based on small studies \\[n=51-91\\], or studies with simplistic or unvalidated FCR measures.\n\nTwo large cohort studies have focused on patient reported health-related QoL after (colorectal) cancer. The English study includes people "living with and beyond cancer", which does not distinguish between survivors with no residual disease, those living with cancer or with a history of recurrence. Furthermore, FCR is assessed with a single item. A Dutch study based on the PROFILES registry used the Impact of Cancer scale (Health Worries subscale) measure, which does not include a proposed cut-off score for clinical FCR. The current study will provide a more definitive estimate of the prevalence of clinical FCR in CRC survivors.\n\nThis study will also explore psychological factors related to FCR in CRC survivors. A cancer diagnosis is life changing and imposes heavy stress on patient and relatives. Together with often numerous physical symptoms and social changes after the cancer treatment, the net sum of stressors may exceed the cancer survivor\'s ability to adapt. This overload may manifest in the experience of bodily symptoms and in some cases develop into a functional disorder/somatic symptom disorder such as bodily distress syndrome or health anxiety, as proposed by Simonelli et al. Bodily distress syndrome is defined as a condition in which the patient suffers from, usually multiple, bodily symptoms in a characteristic pattern not attributable to verifiable, conventionally defined diseases.\n\nHealth anxiety is characterized by preoccupation with fear of having a serious and life-threatening illness with no objective sign of disease, which persists despite medical reassurance. Health anxiety and FCR overlap somewhat, as they both include unpleasant thoughts or ruminations, which interfere with everyday life and may lead to further unnecessary investigations and treatments. One study investigated hypochondriasis in breast cancer survivors and found that 43% of those with a clinical level of FCR met the diagnostic criteria. Two studies of one CRC cohort have measured somatization (i.e. manifestation of physiological distress as physical symptoms), but not links with FCR. To the best of our knowledge, no previous studies have investigated the relationship between functional disorders, FCR, anxiety and depression in CRC survivors.\n\nIllness uncertainty has been linked with FCR and health anxiety. When diagnosed asymptomatic through screening, illness uncertainty might by heightened. Therefore, diagnosis via screening may lead to increased issues in coping with the cancer and FCR. The comprehensive Danish Clinical Cancer Registries contain data on the method of diagnosis, namely whether the CRC survivor was diagnosed through the Danish nationwide Colorectal Cancer Screening Program, as opposed to diagnosed as a result of symptoms. This enables research in this unexplored area of psychosocial consequences of screen-detected cancers.\n\nAround one fourth (26,5%) of CRC survivors and 20-56% of people living with and beyond CRC report psychosocial assistance in coping with FCR to be an important unmet need. Randomized controlled trials testing interventions for reducing FCR have primarily been conducted in breast or mixed cancer survivor populations. Most interventions are based on variations of cognitive-behavioural therapy (CBT). Contemporary CBTs aiming to modify cognitive processes (e.g., attentional bias and beliefs about worry) rather than thought content (e.g. thoughts of death) were more effective (g=0.42 vs 0.24). The delivery format of interventions previously or currently being evaluated has been group, face-to-face, blended, by telephone or by web-based platforms.\n\n"ConquerFear" is an individual face-to-face therapist-delivered intervention with demonstrated efficacy in reducing FCR compared to a relaxation training attention control group of patients with mixed cancers of whom the majority (89%) were women with breast cancer. While use of ConquerFear has been sustained by many study therapists beyond the end of the study, it is a resource and time-consuming approach accessible primarily to those in close proximity to major metropolitan cancer centres with highly trained psychologists. Consequently, a web-based self-management version of ConquerFear has been created (iConquerFear), similar in curriculum content but different in delivery. Qualitative evaluation of the usability of iConquerFear showed: iConquerFear was normalising and empowering; flexible access was key; delivery mode was engaging; tailoring was crucial; links to additional resources were valued.\n\nWeb-based interventions have the potential to fill an important gap in quality cancer care by augmenting limited available mental health services. However, there is some evidence that entirely self-guided web-based FCR interventions may have limited efficacy, and it has been suggested that therapist input may increase efficacy. Web-based therapist-guided cognitive therapy has advantages for both patients and providers and effects appear comparable to traditional face-to-face therapy in treating distress in patients with cancer. Evidence suggests that guided web-based interventions are superior to unguided interventions.\n\nAim The primary aim of this RCT is to test if a therapist-guided version of iConquerFear (TG-iConquerFear) can reduce FCR and improve QoL for CRC survivors more than augmented treatment as usual (aTAU).\n\nSecondary objectives are to i) outline the prevalence of FCR in a population based CRC cohort up to 5 years post-diagnosis using a validated FCR measure with a clinical cut-off. This comprehensive screening will also be used to recruit to the RCT of TG-iConquerFear.\n\nii) outline the prevalence of anxiety, depression, bodily distress syndrome and health anxiety in a population based CRC cohort up to 5 years post-diagnosis.\n\niii) investigate whether being diagnosed as a consequence of the Danish Nation-wide Colorectal Cancer Screening Program increases FCR compared to being diagnosed based on physical symptoms and whether this relationship is mediated by increased uncertainty in illness.\n\niv) investigate whether FCR is associated with anxiety, depression, bodily distress syndrome and health anxiety in CRC survivors, as well as investigate whether uncertainty in illness, negative beliefs about worry and perceived risk of cancer recurrence act as moderators or mediators of these relationships.\n\nv) examine the cost-effectiveness of the TG-iConquerFear intervention versus aTAU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed curative intent colorectal cancer treatment with surgery and/or radiation and/or adjuvant chemotherapy between 1 March 2014 and 31 December 2018\n* No history of recurrence after primary operation\n* Fear of Cancer Recurrence Inventory score of 22 or above (14)\n* Age 18 or above\n* Reads and understands Danish\n* Access and ability to use Internet\n\nExclusion Criteria:\n\n* Cancer recurrence at any follow-up\n* Inability to comply with the protocol due to severe psychiatric, cognitive disorder or substance abuse identified during telephone interview\n* As the intervention is web-based, participants without knowledge of or access to the Internet will be excluded from the RCT (including dyslexia).'}, 'identificationModule': {'nctId': 'NCT04287218', 'briefTitle': 'Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TG-iConquerFear'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'TG-iConquerFear', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['TG-iConquerFear']}, {'name': 'aTAU', 'type': 'BEHAVIORAL', 'otherNames': ['Augmented treatment as usual'], 'description': 'Active control group', 'armGroupLabels': ['Augmented treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Hospital, University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Lars Henrik Jensen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vejle Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available up on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Centre for Oncology Education and Research Translation (CONCERT), Australia', 'class': 'UNKNOWN'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}