Colorectal Cancer Clinical Trial
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
Verified date | May 2024 |
Source | Vejle Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | September 2025 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Denmark | Vejle Hospital, University Hospital of Southern Denmark | Vejle |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital | Aarhus University Hospital, Centre for Oncology Education and Research Translation (CONCERT), Australia, Danish Cancer Society |
Denmark,
Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available. — View Citation
Budtz-Lilly A, Fink P, Ornbol E, Vestergaard M, Moth G, Christensen KS, Rosendal M. A new questionnaire to identify bodily distress in primary care: The 'BDS checklist'. J Psychosom Res. 2015 Jun;78(6):536-45. doi: 10.1016/j.jpsychores.2015.03.006. Epub 2015 Mar 16. — View Citation
Butow P, Williams D, Thewes B, Tesson S, Sharpe L, Smith AB, Fardell JE, Turner J, Gilchrist J, Girgis A, Beith J; Conquer Fear Authorship Group. A psychological intervention (ConquerFear) for treating fear of cancer recurrence: Views of study therapists regarding sustainability. Psychooncology. 2019 Mar;28(3):533-539. doi: 10.1002/pon.4971. Epub 2019 Jan 15. — View Citation
Butow PN, Turner J, Gilchrist J, Sharpe L, Smith AB, Fardell JE, Tesson S, O'Connell R, Girgis A, Gebski VJ, Asher R, Mihalopoulos C, Bell ML, Zola KG, Beith J, Thewes B. Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. J Clin Oncol. 2017 Dec 20;35(36):4066-4077. doi: 10.1200/JCO.2017.73.1257. Epub 2017 Nov 2. — View 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. — View Citation
Chambers SK, Baade P, Meng X, Youl P, Aitken J, Dunn J. Survivor identity after colorectal cancer: antecedents, prevalence and outcomes. Psychooncology. 2012 Sep;21(9):962-9. doi: 10.1002/pon.1991. Epub 2011 May 24. — View Citation
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. — View Citation
Compen F, Bisseling E, Schellekens M, Donders R, Carlson L, van der Lee M, Speckens A. Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2018 Aug 10;36(23):2413-2421. doi: 10.1200/JCO.2017.76.5669. Epub 2018 Jun 28. — View Citation
Costa DSJ, Smith AB, Fardell JE. The sum of all fears: conceptual challenges with measuring fear of cancer recurrence. Support Care Cancer. 2016 Jan;24(1):1-3. doi: 10.1007/s00520-015-2943-y. Epub 2015 Sep 16. — View Citation
Costa DSJ. Screening for clinical levels of fear of cancer recurrence. Psychooncology. 2017 Nov;26(11):2002-2003. doi: 10.1002/pon.4390. Epub 2017 Feb 10. No abstract available. — View Citation
Cruickshank S, Steel E, Fenlon D, Armes J, Scanlon K, Banks E, Humphris G. A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol. Pilot Feasibility Stud. 2017 Jul 20;4:22. doi: 10.1186/s40814-017-0161-8. eCollection 2018. Erratum In: Pilot Feasibility Stud. 2017 Oct 24;3:48. — View Citation
Custers JAE, Gielissen MFM, Janssen SHV, de Wilt JHW, Prins JB. Fear of cancer recurrence in colorectal cancer survivors. Support Care Cancer. 2016 Feb;24(2):555-562. doi: 10.1007/s00520-015-2808-4. Epub 2015 Jun 25. — View Citation
Davidson J, Malloch M, Humphris G. A single-session intervention (the Mini-AFTERc) for fear of cancer recurrence: A feasibility study. Psychooncology. 2018 Nov;27(11):2668-2670. doi: 10.1002/pon.4724. Epub 2018 Apr 30. No abstract available. — View Citation
Deimling GT, Bowman KF, Sterns S, Wagner LJ, Kahana B. Cancer-related health worries and psychological distress among older adult, long-term cancer survivors. Psychooncology. 2006 Apr;15(4):306-20. doi: 10.1002/pon.955. — View Citation
Dieng M, Butow PN, Costa DS, Morton RL, Menzies SW, Mireskandari S, Tesson S, Mann GJ, Cust AE, Kasparian NA. Psychoeducational Intervention to Reduce Fear of Cancer Recurrence in People at High Risk of Developing Another Primary Melanoma: Results of a Randomized Controlled Trial. J Clin Oncol. 2016 Dec 20;34(36):4405-4414. doi: 10.1200/JCO.2016.68.2278. Epub 2016 Oct 28. — View Citation
Downing A, Morris EJ, Richards M, Corner J, Wright P, Sebag-Montefiore D, Finan P, Kind P, Wood C, Lawton S, Feltbower R, Wagland R, Vernon S, Thomas J, Glaser AW. Health-related quality of life after colorectal cancer in England: a patient-reported outcomes study of individuals 12 to 36 months after diagnosis. J Clin Oncol. 2015 Feb 20;33(6):616-24. doi: 10.1200/JCO.2014.56.6539. Epub 2015 Jan 5. — View Citation
Dunn J, Ng SK, Holland J, Aitken J, Youl P, Baade PD, Chambers SK. Trajectories of psychological distress after colorectal cancer. Psychooncology. 2013 Aug;22(8):1759-65. doi: 10.1002/pon.3210. Epub 2012 Nov 5. — View Citation
Eilenberg T, Kronstrand L, Fink P, Frostholm L. Acceptance and commitment group therapy for health anxiety--results from a pilot study. J Anxiety Disord. 2013 Jun;27(5):461-8. doi: 10.1016/j.janxdis.2013.06.001. Epub 2013 Jun 19. — View Citation
Fardell JE, Jones G, Smith AB, Lebel S, Thewes B, Costa D, Tiller K, Simard S, Feldstain A, Beattie S, McCallum M; Conquer Fear authorship group; Butow P. Exploring the screening capacity of the Fear of Cancer Recurrence Inventory-Short Form for clinical levels of fear of cancer recurrence. Psychooncology. 2018 Feb;27(2):492-499. doi: 10.1002/pon.4516. Epub 2017 Aug 18. — View Citation
Fink P, Ewald H, Jensen J, Sorensen L, Engberg M, Holm M, Munk-Jorgensen P. Screening for somatization and hypochondriasis in primary care and neurological in-patients: a seven-item scale for hypochondriasis and somatization. J Psychosom Res. 1999 Mar;46(3):261-73. doi: 10.1016/s0022-3999(98)00092-0. — View Citation
Fink P, Ornbol E, Toft T, Sparle KC, Frostholm L, Olesen F. A new, empirically established hypochondriasis diagnosis. Am J Psychiatry. 2004 Sep;161(9):1680-91. doi: 10.1176/appi.ajp.161.9.1680. — View Citation
Fink P, Schroder A. One single diagnosis, bodily distress syndrome, succeeded to capture 10 diagnostic categories of functional somatic syndromes and somatoform disorders. J Psychosom Res. 2010 May;68(5):415-26. doi: 10.1016/j.jpsychores.2010.02.004. — View Citation
Fisher A, Beeken RJ, Heinrich M, Williams K, Wardle J. Health behaviours and fear of cancer recurrence in 10 969 colorectal cancer (CRC) patients. Psychooncology. 2016 Dec;25(12):1434-1440. doi: 10.1002/pon.4076. Epub 2016 Feb 11. — View Citation
Glaser AW, Fraser LK, Corner J, Feltbower R, Morris EJ, Hartwell G, Richards M, Wagland R. Patient-reported outcomes of cancer survivors in England 1-5 years after diagnosis: a cross-sectional survey. BMJ Open. 2013 Apr 10;3(4):e002317. doi: 10.1136/bmjopen-2012-002317. Print 2013. — View Citation
Hagen KB, Aas T, Lode K, Gjerde J, Lien E, Kvaloy JT, Lash TL, Soiland H, Lind R. Illness uncertainty in breast cancer patients: validation of the 5-item short form of the Mishel Uncertainty in Illness Scale. Eur J Oncol Nurs. 2015 Apr;19(2):113-9. doi: 10.1016/j.ejon.2014.10.009. Epub 2014 Dec 20. — View Citation
Herschbach P, Book K, Dinkel A, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G. Evaluation of two group therapies to reduce fear of progression in cancer patients. Support Care Cancer. 2010 Apr;18(4):471-9. doi: 10.1007/s00520-009-0696-1. Epub 2009 Oct 29. — View Citation
Hovdenak Jakobsen I, Jeppesen MM, Simard S, Thaysen HV, Laurberg S, Juul T. Initial validation of the Danish version of the Fear of Cancer Recurrence Inventory (FCRI) in colorectal cancer patients. J Cancer Surviv. 2018 Dec;12(6):723-732. doi: 10.1007/s11764-018-0709-5. Epub 2018 Aug 20. — View Citation
Jefford M, Ward AC, Lisy K, Lacey K, Emery JD, Glaser AW, Cross H, Krishnasamy M, McLachlan SA, Bishop J. Patient-reported outcomes in cancer survivors: a population-wide cross-sectional study. Support Care Cancer. 2017 Oct;25(10):3171-3179. doi: 10.1007/s00520-017-3725-5. Epub 2017 Apr 22. — View Citation
Koch L, Jansen L, Brenner H, Arndt V. Fear of recurrence and disease progression in long-term (>/= 5 years) cancer survivors--a systematic review of quantitative studies. Psychooncology. 2013 Jan;22(1):1-11. doi: 10.1002/pon.3022. Epub 2012 Jan 10. — View Citation
Kotronoulas G, Papadopoulou C, Burns-Cunningham K, Simpson M, Maguire R. A systematic review of the supportive care needs of people living with and beyond cancer of the colon and/or rectum. Eur J Oncol Nurs. 2017 Aug;29:60-70. doi: 10.1016/j.ejon.2017.05.004. Epub 2017 May 30. — View Citation
Lebel S, Maheu C, Tomei C, Bernstein LJ, Courbasson C, Ferguson S, Harris C, Jolicoeur L, Lefebvre M, Muraca L, Ramanakumar AV, Singh M, Parrott J, Figueiredo D. Towards the validation of a new, blended theoretical model of fear of cancer recurrence. Psychooncology. 2018 Nov;27(11):2594-2601. doi: 10.1002/pon.4880. Epub 2018 Sep 27. — View Citation
Lebel S, Ozakinci G, Humphris G, Mutsaers B, Thewes B, Prins J, Dinkel A, Butow P; University of Ottawa Fear of Cancer Recurrence Colloquium attendees. From normal response to clinical problem: definition and clinical features of fear of cancer recurrence. Support Care Cancer. 2016 Aug;24(8):3265-8. doi: 10.1007/s00520-016-3272-5. Epub 2016 May 12. — View Citation
Lebel S, Simard S, Harris C, Feldstain A, Beattie S, McCallum M, Lefebvre M, Savard J, Devins GM. Empirical validation of the English version of the Fear of Cancer Recurrence Inventory. Qual Life Res. 2016 Feb;25(2):311-321. doi: 10.1007/s11136-015-1088-2. Epub 2015 Sep 4. — View Citation
Leykin Y, Thekdi SM, Shumay DM, Munoz RF, Riba M, Dunn LB. Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. Psychooncology. 2012 Sep;21(9):1016-25. doi: 10.1002/pon.1993. Epub 2011 May 24. — View Citation
Maheu C, Lebel S, Courbasson C, Lefebvre M, Singh M, Bernstein LJ, Muraca L, Benea A, Jolicoeur L, Harris C, Ramanakumar AV, Ferguson S, Sidani S. Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer. BMC Cancer. 2016 Apr 25;16:291. doi: 10.1186/s12885-016-2326-x. — View Citation
McGinty HL, Small BJ, Laronga C, Jacobsen PB. Predictors and patterns of fear of cancer recurrence in breast cancer survivors. Health Psychol. 2016 Jan;35(1):1-9. doi: 10.1037/hea0000238. Epub 2015 Jun 1. — View Citation
McMullen C, Bulkley J, Corley DA, Madrid S, Davis AQ, Hesselbrock R, Kurtilla F, Anderson CK, Arterburn D, Somkin CP, Pawloski PA, Ghai NR, Feigelson HS. Health care improvement and survivorship priorities of colorectal cancer survivors: findings from the PORTAL colorectal cancer cohort survey. Support Care Cancer. 2019 Jan;27(1):147-156. doi: 10.1007/s00520-018-4299-6. Epub 2018 Jun 12. — View Citation
Merckaert I, Lewis F, Delevallez F, Herman S, Caillier M, Delvaux N, Libert Y, Lienard A, Nogaret JM, Ogez D, Scalliet P, Slachmuylder JL, Van Houtte P, Razavi D. Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions. Psychooncology. 2017 Aug;26(8):1147-1154. doi: 10.1002/pon.4294. Epub 2016 Nov 7. — View Citation
Mishel MH. The measurement of uncertainty in illness. Nurs Res. 1981 Sep-Oct;30(5):258-63. — View Citation
Mullens AB, McCaul KD, Erickson SC, Sandgren AK. Coping after cancer: risk perceptions, worry, and health behaviors among colorectal cancer survivors. Psychooncology. 2004 Jun;13(6):367-76. doi: 10.1002/pon.751. — View Citation
Murphy MJ, Newby JM, Butow P, Kirsten L, Allison K, Loughnan S, Price MA, Shaw J, Shepherd H, Smith J, Andrews G. iCanADAPT Early protocol: randomised controlled trial (RCT) of clinician supervised transdiagnostic internet-delivered cognitive behaviour therapy (iCBT) for depression and/or anxiety in early stage cancer survivors -vs- treatment as usual. BMC Cancer. 2017 Mar 15;17(1):193. doi: 10.1186/s12885-017-3182-z. — View Citation
Mutsaers B, Butow P, Dinkel A, Humphris G, Maheu C, Ozakinci G, Prins J, Sharpe L, Smith AB, Thewes B, Lebel S. Identifying the key characteristics of clinical fear of cancer recurrence: An international Delphi study. Psychooncology. 2020 Feb;29(2):430-436. doi: 10.1002/pon.5283. Epub 2019 Nov 25. — View Citation
Nienhuis FJ, van de Willige G, Rijnders CA, de Jonge P, Wiersma D. Validity of a short clinical interview for psychiatric diagnosis: the mini-SCAN. Br J Psychiatry. 2010 Jan;196(1):64-8. doi: 10.1192/bjp.bp.109.066563. — View Citation
PARLOFF MB, KELMAN HC, FRANK JD. Comfort, effectiveness, and self-awareness as criteria of improvement in psychotherapy. Am J Psychiatry. 1954 Nov;111(5):343-52. doi: 10.1176/ajp.111.5.343. No abstract available. — View Citation
Petersen MW, Schroder A, Jorgensen T, Ornbol E, Dantoft TM, Eliasen M, Fink P. RIFD - A brief clinical research interview for functional somatic disorders and health anxiety. J Psychosom Res. 2019 Jul;122:104-111. doi: 10.1016/j.jpsychores.2019.04.001. Epub 2019 Apr 2. — View Citation
Pihlaja S, Stenberg JH, Joutsenniemi K, Mehik H, Ritola V, Joffe G. Therapeutic alliance in guided internet therapy programs for depression and anxiety disorders - A systematic review. Internet Interv. 2017 Nov 17;11:1-10. doi: 10.1016/j.invent.2017.11.005. eCollection 2018 Mar. — View Citation
Short CE, DeSmet A, Woods C, Williams SL, Maher C, Middelweerd A, Muller AM, Wark PA, Vandelanotte C, Poppe L, Hingle MD, Crutzen R. Measuring Engagement in eHealth and mHealth Behavior Change Interventions: Viewpoint of Methodologies. J Med Internet Res. 2018 Nov 16;20(11):e292. doi: 10.2196/jmir.9397. — View Citation
Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15. — View Citation
Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10. — View Citation
Simonelli LE, Siegel SD, Duffy NM. Fear of cancer recurrence: a theoretical review and its relevance for clinical presentation and management. Psychooncology. 2017 Oct;26(10):1444-1454. doi: 10.1002/pon.4168. Epub 2016 Jun 1. — View Citation
Smith A', Sharpe L, Thewes B, Turner J, Gilchrist J, Fardell JE, Girgis A, Tesson S, Descallar J, Bell ML, Beith J, Butow P; ConquerFear Authorship Group. Medical, demographic and psychological correlates of fear of cancer recurrence (FCR) morbidity in breast, colorectal and melanoma cancer survivors with probable clinically significant FCR seeking psychological treatment through the ConquerFear study. Support Care Cancer. 2018 Dec;26(12):4207-4216. doi: 10.1007/s00520-018-4294-y. Epub 2018 Jun 7. — View Citation
Smith AB, Bamgboje-Ayodele A, Butow P, Klein B, Turner J, Sharpe L, Fardell J, Beatty L, Pearce A, Thewes B, Beith J; iConquerFear Community Advisory Group; Girgis A. Development and usability evaluation of an online self-management intervention for fear of cancer recurrence (iConquerFear). Psychooncology. 2020 Jan;29(1):98-106. doi: 10.1002/pon.5218. Epub 2019 Sep 10. — View Citation
Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007 Mar;37(3):319-28. doi: 10.1017/S0033291706008944. Epub 2006 Nov 20. — View Citation
Steele N, Haigh R, Knowles G, Mackean M. Carcinoembryonic antigen (CEA) testing in colorectal cancer follow up: what do patients think? Postgrad Med J. 2007 Sep;83(983):612-4. doi: 10.1136/pgmj.2007.059634. — View Citation
Tauber NM, O'Toole MS, Dinkel A, Galica J, Humphris G, Lebel S, Maheu C, Ozakinci G, Prins J, Sharpe L, Smith AB, Thewes B, Simard S, Zachariae R. Effect of Psychological Intervention on Fear of Cancer Recurrence: A Systematic Review and Meta-Analysis. J Clin Oncol. 2019 Nov 1;37(31):2899-2915. doi: 10.1200/JCO.19.00572. Epub 2019 Sep 18. — View Citation
Thewes B, Bell ML, Butow P, Beith J, Boyle F, Friedlander M, McLachlan SA; Members of the FCR Study Advisory Committee. Psychological morbidity and stress but not social factors influence level of fear of cancer recurrence in young women with early breast cancer: results of a cross-sectional study. Psychooncology. 2013 Dec;22(12):2797-806. doi: 10.1002/pon.3348. Epub 2013 Aug 23. — View Citation
Tomei C, Lebel S, Maheu C, Lefebvre M, Harris C. Examining the preliminary efficacy of an intervention for fear of cancer recurrence in female cancer survivors: a randomized controlled clinical trial pilot study. Support Care Cancer. 2018 Aug;26(8):2751-2762. doi: 10.1007/s00520-018-4097-1. Epub 2018 Mar 2. — View Citation
Tyrer P, Eilenberg T, Fink P, Hedman E, Tyrer H. Health anxiety: the silent, disabling epidemic. BMJ. 2016 Apr 25;353:i2250. doi: 10.1136/bmj.i2250. No abstract available. — View Citation
van de Wal M, Thewes B, Gielissen M, Speckens A, Prins J. Efficacy of Blended Cognitive Behavior Therapy for High Fear of Recurrence in Breast, Prostate, and Colorectal Cancer Survivors: The SWORD Study, a Randomized Controlled Trial. J Clin Oncol. 2017 Jul 1;35(19):2173-2183. doi: 10.1200/JCO.2016.70.5301. Epub 2017 May 4. — View Citation
van de Wal M, van de Poll-Franse L, Prins J, Gielissen M. Does fear of cancer recurrence differ between cancer types? A study from the population-based PROFILES registry. Psychooncology. 2016 Jul;25(7):772-8. doi: 10.1002/pon.4002. Epub 2015 Oct 14. — View Citation
van Helmondt SJ, van der Lee ML, de Vries J. Study protocol of the CAREST-trial: a randomised controlled trial on the (cost-) effectiveness of a CBT-based online self-help training for fear of cancer recurrence in women with curatively treated breast cancer. BMC Cancer. 2016 Jul 25;16:527. doi: 10.1186/s12885-016-2562-0. — View Citation
van Helmondt SJ, van der Lee ML, van Woezik RAM, Lodder P, de Vries J. No effect of CBT-based online self-help training to reduce fear of cancer recurrence: First results of the CAREST multicenter randomized controlled trial. Psychooncology. 2020 Jan;29(1):86-97. doi: 10.1002/pon.5233. Epub 2019 Nov 13. — View Citation
Veddegjaerde KE, Sivertsen B, Wilhelmsen I, Skogen JC. Confirmatory factor analysis and item response theory analysis of the Whiteley Index. Results from a large population based study in Norway. The Hordaland Health Study (HUSK). J Psychosom Res. 2014 Sep;77(3):213-8. doi: 10.1016/j.jpsychores.2014.06.011. Epub 2014 Jun 28. — View Citation
Waters EA, Arora NK, Klein WM, Han PK. Perceived risk, trust and health-related quality of life among cancer survivors. Ann Behav Med. 2010 Feb;39(1):91-7. doi: 10.1007/s12160-010-9163-y. — View 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. — View Citation
Willems RA, Bolman CA, Mesters I, Kanera IM, Beaulen AA, Lechner L. Cancer survivors in the first year after treatment: the prevalence and correlates of unmet needs in different domains. Psychooncology. 2016 Jan;25(1):51-7. doi: 10.1002/pon.3870. Epub 2015 Jun 25. — View Citation
* Note: There are 66 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in uncertainty in illness as evaluated by Mishels Uncertainty of Illness Scale (MUIS). | Process measures. Questionnaire | Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months | |
Other | Change of negative beliefs about worry evaluated by MetaCognitions Questionnaire-30. | Process measures. Questionnaire | Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months | |
Other | Perceived risk of recurrence measured by the visual analogue scale from 1-100 | Process measures. Scale. | Twice during the intervention, 1-14 days after the intervention and after 3, 6, and 12 months | |
Primary | Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline to 2nd follow-up | Questionnaire | 3 months post-intervention | |
Secondary | Change of total score on Fear of Cancer Recurrence Inventory (FCRI) from baseline | Questionnaire | 1-14 days after intervention and after 6 and 12 months | |
Secondary | Change in Bodily Distress Syndrome from baseline as evaluated by the BDS Checklist | Questionnaire | 1-14 days after intervention and after 6 and 12 months | |
Secondary | Change in anxiety and depression from baseline as evaluated by the relevant Symptom Checklist-90-R | Questionnaire | 1-14 days after intervention and after 6 and 12 months | |
Secondary | Change in health anxiety from baseline as measured by the Whiteley-6 index | Questionnaire | 1-14 days after intervention and after 6 and 12 months | |
Secondary | Evaluation of cost-effectiveness of TG-iConquerFear | Information will be extracted from Danish registries. | Max. 27 months | |
Secondary | Comparison of changes in health care usage between intervention arm and aTAU | Information will be extracted from Danish registries. | Max. 27 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |