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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01264562

DKH 109132

Details and patient eligibility

About

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.

Full 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

Enrollment: 254 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

254 participants in 3 patient groups

Chemotherapy group

Description:

Breast cancer patients treated with chemotherapy

Non-chemotherapy group

Description:

Breast cancer patients not treated with chemotherapy

Healthy controls

Description:

Women without a cancer diagnosis, matched for age and education