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Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment. (CINDERELLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05196269

Recruitment Status : Recruiting

First Posted : January 19, 2022

Last Update Posted : March 21, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

European Commission

INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal)

Cankado GmbH

FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal)

Bocconi University

Information provided by (Responsible Party):

Maria-Joao Cardoso, Fundacao Champalimaud

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	December 2024
Estimated Study Completion Date :	December 2025

Publications:

Pilleron S, Soto-Perez-de-Celis E, Vignat J, Ferlay J, Soerjomataram I, Bray F, Sarfati D. Estimated global cancer incidence in the oldest adults in 2018 and projections to 2050. Int J Cancer. 2021 Feb 1;148(3):601-608. doi: 10.1002/ijc.33232. Epub 2020 Aug 17.

Kim MK, Kim T, Moon HG, Jin US, Kim K, Kim J, Lee JW, Kim J, Lee E, Yoo TK, Noh DY, Minn KW, Han W. Effect of cosmetic outcome on quality of life after breast cancer surgery. Eur J Surg Oncol. 2015 Mar;41(3):426-32. doi: 10.1016/j.ejso.2014.12.002. Epub 2014 Dec 19.

Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.

Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer. 2020 Jul;27(4):534-566. doi: 10.1007/s12282-020-01076-1. Epub 2020 Mar 12.

Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.

Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.

Ong WL, Schouwenburg MG, van Bommel ACM, Stowell C, Allison KH, Benn KE, Browne JP, Cooter RD, Delaney GP, Duhoux FP, Ganz PA, Hancock P, Jagsi R, Knaul FM, Knip AM, Koppert LB, Kuerer HM, McLaughin S, Mureau MAM, Partridge AH, Reid DP, Sheeran L, Smith TJ, Stoutjesdijk MJ, Vrancken Peeters MJTFD, Wengstrom Y, Yip CH, Saunders C. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017 May 1;3(5):677-685. doi: 10.1001/jamaoncol.2016.4851.

Ciani O, Federici CB. Value Lies in the Eye of the Patients: The Why, What, and How of Patient-reported Outcomes Measures. Clin Ther. 2020 Jan;42(1):25-33. doi: 10.1016/j.clinthera.2019.11.016. Epub 2020 Jan 10.

Fitzal F, Krois W, Trischler H, Wutzel L, Riedl O, Kuhbelbock U, Wintersteiner B, Cardoso MJ, Dubsky P, Gnant M, Jakesz R, Wild T. The use of a breast symmetry index for objective evaluation of breast cosmesis. Breast. 2007 Aug;16(4):429-35. doi: 10.1016/j.breast.2007.01.013. Epub 2007 Mar 26.

Cardoso MJ, Cardoso J, Amaral N, Azevedo I, Barreau L, Bernardo M, Christie D, Costa S, Fitzal F, Fougo JL, Johansen J, Macmillan D, Mano MP, Regolo L, Rosa J, Teixeira L, Vrieling C. Turning subjective into objective: the BCCT.core software for evaluation of cosmetic results in breast cancer conservative treatment. Breast. 2007 Oct;16(5):456-61. doi: 10.1016/j.breast.2007.05.002. Epub 2007 Jul 2.

Cardoso JS, Cardoso MJ. Towards an intelligent medical system for the aesthetic evaluation of breast cancer conservative treatment. Artif Intell Med. 2007 Jun;40(2):115-26. doi: 10.1016/j.artmed.2007.02.007. Epub 2007 Apr 8.

Heil J, Dahlkamp J, Golatta M, Rom J, Domschke C, Rauch G, Cardoso MJ, Sohn C. Aesthetics in breast conserving therapy: do objectively measured results match patients' evaluations? Ann Surg Oncol. 2011 Jan;18(1):134-8. doi: 10.1245/s10434-010-1252-4. Epub 2010 Aug 10.

Cardoso MJ, Cardoso JS, Oliveira HP, Gouveia P. The breast cancer conservative treatment. Cosmetic results - BCCT.core - Software for objective assessment of esthetic outcome in breast cancer conservative treatment: A narrative review. Comput Methods Programs Biomed. 2016 Apr;126:154-9. doi: 10.1016/j.cmpb.2015.11.010. Epub 2015 Dec 9.

Cardoso JS, Silva W, Cardoso MJ. Evolution, current challenges, and future possibilities in the objective assessment of aesthetic outcome of breast cancer locoregional treatment. Breast. 2020 Feb;49:123-130. doi: 10.1016/j.breast.2019.11.006. Epub 2019 Nov 21.

Ciani O, Salcher-Konrad M, Meregaglia M, Smith K, Gorst SL, Dodd S, Williamson PR, Fattore G. Patient-reported outcome measures in core outcome sets targeted overlapping domains but through different instruments. J Clin Epidemiol. 2021 Aug;136:26-36. doi: 10.1016/j.jclinepi.2021.03.003. Epub 2021 Mar 6.

van Egdom LSE, Pusic A, Verhoef C, Hazelzet JA, Koppert LB. Machine learning with PROs in breast cancer surgery; caution: Collecting PROs at baseline is crucial. Breast J. 2020 Jun;26(6):1213-1215. doi: 10.1111/tbj.13804. Epub 2020 Mar 11.

Pfob A, Sidey-Gibbons C, Schuessler M, Lu SC, Xu C, Dubsky P, Golatta M, Heil J. Contrast of Digital and Health Literacy Between IT and Health Care Specialists Highlights the Importance of Multidisciplinary Teams for Digital Health-A Pilot Study. JCO Clin Cancer Inform. 2021 Jun;5:734-745. doi: 10.1200/CCI.21.00032.

Brunet J, Price J. A scoping review of measures used to assess body image in women with breast cancer. Psychooncology. 2021 May;30(5):669-680. doi: 10.1002/pon.5619. Epub 2021 Jan 21.

Flitcroft K, Brennan M, Spillane A. Women's expectations of breast reconstruction following mastectomy for breast cancer: a systematic review. Support Care Cancer. 2017 Aug;25(8):2631-2661. doi: 10.1007/s00520-017-3712-x. Epub 2017 May 4.

Fuzesi S, Becetti K, Klassen AF, Gemignani ML, Pusic AL. Expectations of breast-conserving therapy: a qualitative study. J Patient Rep Outcomes. 2019 Dec 27;3(1):73. doi: 10.1186/s41687-019-0167-5.

Biganzoli L, Marotti L, Hart CD, Cataliotti L, Cutuli B, Kuhn T, Mansel RE, Ponti A, Poortmans P, Regitnig P, van der Hage JA, Wengstrom Y, Rosselli Del Turco M. Quality indicators in breast cancer care: An update from the EUSOMA working group. Eur J Cancer. 2017 Nov;86:59-81. doi: 10.1016/j.ejca.2017.08.017. Epub 2017 Sep 28.

Cano SJ, Klassen AF, Scott AM, Pusic AL. A closer look at the BREAST-Q((c)). Clin Plast Surg. 2013 Apr;40(2):287-96. doi: 10.1016/j.cps.2012.12.002.

Preuss J, Lester L, Saunders C. BCCT.core - can a computer program be used for the assessment of aesthetic outcome after breast reconstructive surgery? Breast. 2012 Aug;21(4):597-600. doi: 10.1016/j.breast.2012.05.012. Epub 2012 Jun 17.

Berger VW, Bour LJ, Carter K, Chipman JJ, Everett CC, Heussen N, Hewitt C, Hilgers RD, Luo YA, Renteria J, Ryeznik Y, Sverdlov O, Uschner D; Randomization Innovative Design Scientific Working Group. A roadmap to using randomization in clinical trials. BMC Med Res Methodol. 2021 Aug 16;21(1):168. doi: 10.1186/s12874-021-01303-z.