Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
NCT ID: NCT01264562
Last Updated: 2016-05-03
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
254 participants
OBSERVATIONAL
2011-01-31
2014-10-31
Brief Summary
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Detailed Description
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\*The adverse effects of cancer and cancer therapy on cognitive function in breast cancer patients are entirely or partly mediated by stress and the ensuing dysfunction of the HPA-axis.
Secondary objectives:
* Determining the effect of cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on the HPA-axis in breast cancer patients
* Determining the effect of cognitive dysfunction assessed with neuropsychological tests, cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on subjective cognitive function in breast cancer patients
* Prevalence of acute stress response, posttraumatic stress disorder and posttraumatic stress symptoms, and extent of cancer-specific stress in breast cancer patients treated with or without chemotherapy
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chemotherapy group
Breast cancer patients treated with chemotherapy
No interventions assigned to this group
Non-chemotherapy group
Breast cancer patients not treated with chemotherapy
No interventions assigned to this group
Healthy controls
Women without a cancer diagnosis, matched for age and education
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* informed consent
* breast diagnostics with benign result (no treatment necessary)
* informed consent
Exclusion Criteria
* substance abuse
* history of psychosis
* history of neurologic disorder
* previous systemic cancer treatment
* Addison' disease
* Cushing's syndrome
18 Years
65 Years
FEMALE
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Kerstin Hermelink
Study Principal Investigator
Principal Investigators
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Kerstin Hermelink, PhD
Role: PRINCIPAL_INVESTIGATOR
Ludwig Maximilian University, Department of Gynecology and Obstetrics
Locations
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Frauenklinik des Helios Amper Klinikums Dachau
Dachau, Bavaria, Germany
Kreisklinik Ebersberg
Ebersberg, Bavaria, Germany
Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services
Landshut, Bavaria, Germany
Rotkreuzklinikum Muenchen
Munich, Bavaria, Germany
Klinikum Dritter Orden
Munich, Bavaria, Germany
Ludwig Maximilian University, Department of Gynecology and Obstetrics
Munich, Bavaria, Germany
Countries
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References
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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.
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.
Related Links
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website of the Ludwig Maximilian University of Munich, Breast Cancer Center, Psycho-Oncology
Other Identifiers
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DKH 109132
Identifier Type: -
Identifier Source: org_study_id
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