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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	254 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Study Start Date :	January 2011
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Course of cognitive function [ Time Frame: 12 months ]
   Performance on a battery of cognitive tests

Secondary Outcome Measures :

1. Course of subjective cognitive function [ Time Frame: 12 months ]
   Self-reported cognitive problems
2. Course of the HPA-axis function [ Time Frame: 12 months ]
   Cortisol awakening response and diurnal profile
3. Course of the stress response [ Time Frame: 12 months ]
   Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress

Biospecimen Retention:   Samples Without DNA

Saliva

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

Principal Investigator:	Kerstin Hermelink, PhD	Ludwig Maximilian University, Department of Gynecology and Obstetrics

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Publications of Results:

Hermelink K, Voigt V, Kaste J, Neufeld F, Wuerstlein R, Bühner M, Münzel K, Rjosk-Dendorfer D, Grandl S, Braun M, von Koch FE, Härtl K, Hasmüller 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). pii: djv099. doi: 10.1093/jnci/djv099. Print 2015 Jul.

Voigt V, Neufeld F, Kaste J, Bühner M, Sckopke P, Wuerstlein R, Hellerhoff K, Sztrókay-Gaul A, Braun M, von Koch FE, Silva-Zürcher E, Hasmüller 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.

Other Publications:

Hermelink K, Bühner M, Harbeck N. Response. J Natl Cancer Inst. 2016 Apr 13;108(8). pii: djw049. doi: 10.1093/jnci/djw049. Print 2016 Aug.

Responsible Party:	Kerstin Hermelink, Study Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT01264562 History of Changes
Other Study ID Numbers:	DKH 109132
First Posted:	December 22, 2010
Last Update Posted:	May 3, 2016
Last Verified:	May 2016

Keywords provided by Kerstin Hermelink, Ludwig-Maximilians - University of Munich:

chemotherapy, adjuvant; adverse effects; breast neoplasms	cognition disorders; Stress Disorders, post-traumatic; cortisol

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases