NCT01264562

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 254 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-12-22
• Last updated: 2016-05-03

Locations

6 sites across 1 country: Germany