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| Name | Class |
|---|---|
| Deutsche Krebshilfe e.V., Bonn (Germany) | OTHER |
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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.
Primary hypothesis:
*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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy group | Breast cancer patients treated with chemotherapy | ||
| Non-chemotherapy group | Breast cancer patients not treated with chemotherapy | ||
| Healthy controls | Women without a cancer diagnosis, matched for age and education |
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| Measure | Description | Time Frame |
|---|---|---|
| Course of cognitive function | Performance on a battery of cognitive tests | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Course of subjective cognitive function | Self-reported cognitive problems | 12 months |
| Course of the HPA-axis function | Cortisol awakening response and diurnal profile |
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Inclusion Criteria, both patient groups:
Inclusion Criteria, healthy control group:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Kerstin Hermelink, PhD | Ludwig Maximilian University, Department of Gynecology and Obstetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frauenklinik des Helios Amper Klinikums Dachau | Dachau | Bavaria | 85221 | Germany | ||
| Kreisklinik Ebersberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27075856 | Background | 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. | |
| 25882713 | Result | 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. |
| Label | URL |
|---|---|
| website of the Ludwig Maximilian University of Munich, Breast Cancer Center, Psycho-Oncology | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003072 | Cognition Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Saliva
| 12 months |
| Course of the stress response | Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress | 12 months |
| 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 |
| 26898732 | Result | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |