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Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress (Cognicares)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264562
First Posted: December 22, 2010
Last Update Posted: May 3, 2016
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. Read our disclaimer for details.
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Kerstin Hermelink, Ludwig-Maximilians - University of Munich
December 20, 2010
December 22, 2010
May 3, 2016
January 2011
October 2014   (Final data collection date for primary outcome measure)
Course of cognitive function [ Time Frame: 12 months ]
Performance on a battery of cognitive tests
Course of cognitive function [ Time Frame: 18 months ]
Performance on a battery of cognitive tests
Complete list of historical versions of study NCT01264562 on ClinicalTrials.gov Archive Site
  • Course of subjective cognitive function [ Time Frame: 12 months ]
    Self-reported cognitive problems
  • Course of the HPA-axis function [ Time Frame: 12 months ]
    Cortisol awakening response and diurnal profile
  • Course of the stress response [ Time Frame: 12 months ]
    Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
  • Course of subjective cognitive function [ Time Frame: 18 months ]
    Self-reported cognitive problems
  • Course of the HPA-axis function [ Time Frame: 18 months ]
    Cortisol awakening response and diurnal profile
  • Course of the stress response [ Time Frame: 18 months ]
    Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
Not Provided
Not Provided
 
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
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:

  • 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
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Saliva
Probability Sample
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
Breast Cancer
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria, both patient groups:

  • primary breast cancer, stage 0-IIIc, therapy not yet started
  • informed consent

Inclusion Criteria, healthy control group:

  • breast diagnostics with benign result (no treatment necessary)
  • informed consent

Exclusion Criteria:

  • not fluent in German
  • substance abuse
  • history of psychosis
  • history of neurologic disorder
  • previous systemic cancer treatment
  • Addison' disease
  • Cushing's syndrome
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01264562
DKH 109132
No
Not Provided
Not Provided
Kerstin Hermelink, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Deutsche Krebshilfe e.V., Bonn (Germany)
Principal Investigator: Kerstin Hermelink, PhD Ludwig Maximilian University, Department of Gynecology and Obstetrics
Ludwig-Maximilians - University of Munich
May 2016