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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01264562
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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

Study Timeline

• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Study Start: 2011-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-01
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 254

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of cognitive function	12 months	Performance on a battery of cognitive tests

Secondary Outcome Measures

Name	Time	Method
Course of subjective cognitive function	12 months	Self-reported cognitive problems
Course of the stress response	12 months	Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
Course of the HPA-axis function	12 months	Cortisol awakening response and diurnal profile

Trial Locations

Locations (6)

Frauenklinik des Helios Amper Klinikums Dachau; 🇩🇪 Dachau, Bavaria, Germany

Klinikum Dritter Orden; 🇩🇪 Munich, Bavaria, Germany

Kreisklinik Ebersberg; 🇩🇪 Ebersberg, Bavaria, Germany

Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services; 🇩🇪 Landshut, Bavaria, Germany

Ludwig Maximilian University, Department of Gynecology and Obstetrics; 🇩🇪 Munich, Bavaria, Germany

Rotkreuzklinikum Muenchen; 🇩🇪 Munich, Bavaria, Germany