Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Ludwig-Maximilians - University of Munich
- Enrollment
- 254
- Locations
- 6
- Primary Endpoint
- Course of cognitive function
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Kerstin Hermelink
Study Principal Investigator
Ludwig-Maximilians - University of Munich
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •not fluent in German
- •substance abuse
- •history of psychosis
- •history of neurologic disorder
- •previous systemic cancer treatment
- •Addison' disease
- •Cushing's syndrome
Outcomes
Primary Outcomes
Course of cognitive function
Time Frame: 12 months
Performance on a battery of cognitive tests
Secondary Outcomes
- Course of subjective cognitive function(12 months)
- Course of the stress response(12 months)
- Course of the HPA-axis function(12 months)