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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Kerstin Hermelink, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01264562
First received: December 20, 2010
Last updated: April 1, 2014
Last verified: April 2014

December 20, 2010
April 1, 2014
January 2011
July 2014   (final data collection date for primary outcome measure)
Course of cognitive function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Performance on a battery of cognitive tests
Course of cognitive function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    Self-reported cognitive problems
  • Course of the HPA-axis function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cortisol awakening response and diurnal profile
  • Course of the stress response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
  • Course of subjective cognitive function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Self-reported cognitive problems
  • Course of the HPA-axis function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Cortisol awakening response and diurnal profile
  • Course of the stress response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
October 2014
July 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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01264562
DKH 109132
No
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
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP