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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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 Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Dachau, Bavaria, Germany, 85221
      • Frauenklinik des Helios Amper Klinikums Dachau
    • Ebersberg, Bavaria, Germany, 85560
      • Kreisklinik Ebersberg
    • Landshut, Bavaria, Germany, 84034
      • Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services
    • Munich, Bavaria, Germany, 80634
      • Rotkreuzklinikum Muenchen
    • Munich, Bavaria, Germany, 80638
      • Klinikum Dritter Orden
    • Munich, Bavaria, Germany, 81377
      • Ludwig Maximilian University, Department of Gynecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients of the Ludwig Maximilian University of Munich Breast Cancer Center; Klinikum Landshut Department of Obstetrics and Gynecology and Breast Cancer Services; Kreisklinik Ebersberg Department of Gynecology and Obstetrics; Klinikum Dritter Orden Department of Gynecology and Obstetrics; Rotkreuzklinikum Muenchen Department of Gynecology and Obstetrics, Helios Amper Hospital Dachau, Department of Gynecology and Obstetrics

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Chemotherapy group; Breast cancer patients treated with chemotherapy
Non-chemotherapy group; Breast cancer patients not treated with chemotherapy
Healthy controls; Women without a cancer diagnosis, matched for age and education

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
• Investigators: Principal Investigator: Kerstin Hermelink, PhD, Ludwig Maximilian University, Department of Gynecology and Obstetrics

Publications and helpful links

General Publications

• Hermelink K, Buhner M, Harbeck N. Response. J Natl Cancer Inst. 2016 Apr 13;108(8):djw049. doi: 10.1093/jnci/djw049. Print 2016 Aug. No abstract available.
• Hermelink K, Voigt V, Kaste J, Neufeld F, Wuerstlein R, Buhner M, Munzel K, Rjosk-Dendorfer D, Grandl S, Braun M, von Koch FE, Hartl K, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Harbeck N. Elucidating pretreatment cognitive impairment in breast cancer patients: the impact of cancer-related post-traumatic stress. J Natl Cancer Inst. 2015 Apr 16;107(7):djv099. doi: 10.1093/jnci/djv099. Print 2015 Jul.
• Voigt V, Neufeld F, Kaste J, Buhner M, Sckopke P, Wuerstlein R, Hellerhoff K, Sztrokay-Gaul A, Braun M, von Koch FE, Silva-Zurcher E, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Mahner S, Harbeck N, Hermelink K. Clinically assessed posttraumatic stress in patients with breast cancer during the first year after diagnosis in the prospective, longitudinal, controlled COGNICARES study. Psychooncology. 2017 Jan;26(1):74-80. doi: 10.1002/pon.4102. Epub 2016 Feb 22.

Helpful Links

• website of the Ludwig Maximilian University of Munich, Breast Cancer Center, Psycho-Oncology

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 22, 2010

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: breast neoplasms; cortisol; adverse effects; cognition disorders; chemotherapy, adjuvant; Stress Disorders, post-traumatic
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DKH 109132