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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy group<br>Breast cancer patients treated with chemotherapy | |
| Non-chemotherapy group<br>Breast cancer patients not treated with chemotherapy | |
| Healthy controls<br>Women without a cancer diagnosis, matched for age and education | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of cognitive function | Performance on a battery of cognitive tests | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 
| Course of the stress response | Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, adjuvant, adverse effects, breast neoplasms, cognition disorders, Stress Disorders, post-traumatic, cortisol