Quality of Life of Patients With Desmoid-type Fibromatosis
NCT ID: NCT04289077
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
156 participants
OBSERVATIONAL
2020-08-06
2021-02-01
Brief Summary
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Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.
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Detailed Description
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Outline: All patients, aged above 18 years, with a histopathological proved DTF tumour and sufficient Dutch language skills who have received their last check-up in the hospital within the last five years (April 2014). Patients treated in one of the participating centres, will be asked to fill out a set of questionnaires (baseline questionnaire, health care utilization, decision making, EORTC QLQ-C30, DTF-specific questionnaire, and the EQ-5D-5L). Patients will only have to fill out these questionnaires once.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients with histopathological proven DTF
Questionnaires
\- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October
Interventions
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Questionnaires
\- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October
Eligibility Criteria
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Inclusion Criteria
* Histopathological proven DTF, regardless of disease stage or treatment.
* Diagnosed between January 1990 and July 2020, with a visit to the hospital for their DTF (between October 2014 and July 2020)
* Sufficient Dutch language skills
* Competent to complete a questionnaire
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
The Netherlands Cancer Institute
OTHER
Royal Marsden NHS Foundation Trust
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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C. Verhoef
Prof. dr. C. Verhoef, MD, PhD
Principal Investigators
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C. Verhoef, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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3. Antoni van Leeuwenhoek Ziekenhuis (AVL) / The Netherlands Cancer Instituut , Amsterdam, The Netherlands
Amsterdam, , Netherlands
Radboud University Medical Center (MC), Nijmegen, The Netherlands
Nijmegen, , Netherlands
Erasmus MC Cancer Institute
Rotterdam, , Netherlands
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Kasper B, Baumgarten C, Garcia J, Bonvalot S, Haas R, Haller F, Hohenberger P, Penel N, Messiou C, van der Graaf WT, Gronchi A; Desmoid Working Group. An update on the management of sporadic desmoid-type fibromatosis: a European Consensus Initiative between Sarcoma PAtients EuroNet (SPAEN) and European Organization for Research and Treatment of Cancer (EORTC)/Soft Tissue and Bone Sarcoma Group (STBSG). Ann Oncol. 2017 Oct 1;28(10):2399-2408. doi: 10.1093/annonc/mdx323.
Posner MC, Shiu MH, Newsome JL, Hajdu SI, Gaynor JJ, Brennan MF. The desmoid tumor. Not a benign disease. Arch Surg. 1989 Feb;124(2):191-6. doi: 10.1001/archsurg.1989.01410020061010.
Crago AM, Denton B, Salas S, Dufresne A, Mezhir JJ, Hameed M, Gonen M, Singer S, Brennan MF. A prognostic nomogram for prediction of recurrence in desmoid fibromatosis. Ann Surg. 2013 Aug;258(2):347-53. doi: 10.1097/SLA.0b013e31828c8a30.
Gronchi A, Colombo C, Le Pechoux C, Dei Tos AP, Le Cesne A, Marrari A, Penel N, Grignani G, Blay JY, Casali PG, Stoeckle E, Gherlinzoni F, Meeus P, Mussi C, Gouin F, Duffaud F, Fiore M, Bonvalot S; ISG and FSG. Sporadic desmoid-type fibromatosis: a stepwise approach to a non-metastasising neoplasm--a position paper from the Italian and the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):578-583. doi: 10.1093/annonc/mdt485. Epub 2013 Dec 9.
Gundle KR, Cizik AM, Jones RL, Davidson DJ. Quality of life measures in soft tissue sarcoma. Expert Rev Anticancer Ther. 2015 Jan;15(1):95-100. doi: 10.1586/14737140.2015.972947. Epub 2014 Nov 7.
Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. doi: 10.1056/NEJMoa1805052.
Husson O, Younger E, Dunlop A, Dean L, Strauss DC, Benson C, Hayes AJ, Miah A, van Houdt W, Zaidi S, Smith M, Williams J, Jones RL, van der Graaf WTA. Desmoid fibromatosis through the patients' eyes: time to change the focus and organisation of care? Support Care Cancer. 2019 Mar;27(3):965-980. doi: 10.1007/s00520-018-4386-8. Epub 2018 Aug 28.
van Broekhoven DL, Grunhagen DJ, den Bakker MA, van Dalen T, Verhoef C. Time trends in the incidence and treatment of extra-abdominal and abdominal aggressive fibromatosis: a population-based study. Ann Surg Oncol. 2015 Sep;22(9):2817-23. doi: 10.1245/s10434-015-4632-y. Epub 2015 Jun 5.
Bonvalot S, Ternes N, Fiore M, Bitsakou G, Colombo C, Honore C, Marrari A, Le Cesne A, Perrone F, Dunant A, Gronchi A. Spontaneous regression of primary abdominal wall desmoid tumors: more common than previously thought. Ann Surg Oncol. 2013 Dec;20(13):4096-102. doi: 10.1245/s10434-013-3197-x. Epub 2013 Sep 20.
Penel N, Le Cesne A, Bonvalot S, Giraud A, Bompas E, Rios M, Salas S, Isambert N, Boudou-Rouquette P, Honore C, Italiano A, Ray-Coquard I, Piperno-Neumann S, Gouin F, Bertucci F, Ryckewaert T, Kurtz JE, Ducimetiere F, Coindre JM, Blay JY. Surgical versus non-surgical approach in primary desmoid-type fibromatosis patients: A nationwide prospective cohort from the French Sarcoma Group. Eur J Cancer. 2017 Sep;83:125-131. doi: 10.1016/j.ejca.2017.06.017. Epub 2017 Jul 20.
Timbergen MJM, van de Poll-Franse LV, Grunhagen DJ, van der Graaf WT, Sleijfer S, Verhoef C, Husson O. Identification and assessment of health-related quality of life issues in patients with sporadic desmoid-type fibromatosis: a literature review and focus group study. Qual Life Res. 2018 Dec;27(12):3097-3111. doi: 10.1007/s11136-018-1931-3. Epub 2018 Jul 16.
Nolte S, Liegl G, Petersen MA, Aaronson NK, Costantini A, Fayers PM, Groenvold M, Holzner B, Johnson CD, Kemmler G, Tomaszewski KA, Waldmann A, Young TE, Rose M; EORTC Quality of Life Group. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019 Jan;107:153-163. doi: 10.1016/j.ejca.2018.11.024. Epub 2018 Dec 19.
Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MA, Velikova G, Aaronson NK; EORTC Quality of Life Group. Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol. 2016 Jan;69:79-88. doi: 10.1016/j.jclinepi.2015.08.007. Epub 2015 Sep 28.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MEC-2019-0816
Identifier Type: -
Identifier Source: org_study_id
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