NCT01264562|Completed
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Cognicares
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Cognicares
Sponsor study identifier
observational
254
1 country
6
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2010
Actual (reported)December 22, 2010
Actual (reported)January 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 2014
Actual (reported)October 2014
Actual (reported)Course of cognitive function
Performance on a battery of cognitive tests
12 months
Course of subjective cognitive function
12 months
Course of the HPA-axis function
12 months
Course of the stress response
12 months
Breast cancer patients treated with chemotherapy
Breast cancer patients not treated with chemotherapy
Women without a cancer diagnosis, matched for age and education
Patients of the Ludwig Maximilian University of Munich Breast Cancer Center; Klinikum Landshut Department of Obstetrics and Gynecology and Breast Cancer Services; Kreisklinik Ebersberg Department of Gynecology and Obstetrics; Klinikum Dritter Orden Department of Gynecology and Obstetrics; Rotkreuzklinikum Muenchen Department of Gynecology and Obstetrics, Helios Amper Hospital Dachau, Department of Gynecology and Obstetrics
Frauenklinik des Helios Amper Klinikums Dachau
Dachau, Bavaria, 85221, Germany
Kreisklinik Ebersberg
Ebersberg, Bavaria, 85560, Germany
Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services
Landshut, Bavaria, 84034, Germany
Rotkreuzklinikum Muenchen
Munich, Bavaria, 80634, Germany
Klinikum Dritter Orden
Munich, Bavaria, 80638, Germany
Ludwig Maximilian University, Department of Gynecology and Obstetrics
Munich, Bavaria, 81377, Germany
Hermelink K, Buhner M, Harbeck N. Response. J Natl Cancer Inst. 2016 Apr 13;108(8):djw049. doi: 10.1093/jnci/djw049. Print 2016 Aug. No abstract available.
Hermelink K, Voigt V, Kaste J, Neufeld F, Wuerstlein R, Buhner M, Munzel K, Rjosk-Dendorfer D, Grandl S, Braun M, von Koch FE, Hartl K, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Harbeck N. Elucidating pretreatment cognitive impairment in breast cancer patients: the impact of cancer-related post-traumatic stress. J Natl Cancer Inst. 2015 Apr 16;107(7):djv099. doi: 10.1093/jnci/djv099. Print 2015 Jul.
Saliva
Kerstin Hermelink, PhD
Ludwig Maximilian University, Department of Gynecology and Obstetrics
254 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2010
First Posted
December 22, 2010
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Adjuvant Whole Breast Radiotherapy (RT) With Intensity Modulated Radiotherapy (IMRT) and a Simultaneous Integrated Boost Versus Conventional RT and a Sequential Boost
Contact the study team to confirm eligibility.
Voigt V, Neufeld F, Kaste J, Buhner M, Sckopke P, Wuerstlein R, Hellerhoff K, Sztrokay-Gaul A, Braun M, von Koch FE, Silva-Zurcher E, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Mahner S, Harbeck N, Hermelink K. Clinically assessed posttraumatic stress in patients with breast cancer during the first year after diagnosis in the prospective, longitudinal, controlled COGNICARES study. Psychooncology. 2017 Jan;26(1):74-80. doi: 10.1002/pon.4102. Epub 2016 Feb 22.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
May 3, 2016
Record last verified: 2016-05
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