Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress (Cognicares)
This study is currently recruiting participants.
Verified December 2011 by Ludwig-Maximilians - University of Munich
Sponsor:
Ludwig-Maximilians - University of Munich
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Kerstin Hermelink, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01264562
First received: December 20, 2010
Last updated: December 28, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress |
Resource links provided by NLM:
Further study details as provided by Ludwig-Maximilians - University of Munich:
Primary Outcome Measures:
- Course of cognitive function [ Time Frame: 12 months ] [ Designated as safety issue: No ]Performance on a battery of cognitive tests
Secondary Outcome Measures:
- Course of subjective cognitive function [ Time Frame: 12 months ] [ Designated as safety issue: No ]Self-reported cognitive problems
- Course of the HPA-axis function [ Time Frame: 12 months ] [ Designated as safety issue: No ]Cortisol awakening response and diurnal profile
- Course of the stress response [ Time Frame: 12 months ] [ Designated as safety issue: No ]Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
Biospecimen Retention: Samples Without DNA
Saliva
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264562
Contacts
| Contact: Kerstin Hermelink, PhD | +49 (0) 89 7095-0 ext 7595 | kerstin.hermelink@med.uni-muenchen.de |
| Contact: Judith Kaste, Dipl.-Psych. | +49 (0) 89 7095-0 ext 7578 | Judith.Kaste@med.uni-muenchen.de |
Locations
| Germany | |
| Kreisklinik Ebersberg | Recruiting |
| Ebersberg, Bavaria, Germany, 85560 | |
| Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services | Recruiting |
| Landshut, Bavaria, Germany, 84034 | |
| Ludwig Maximilian University, Department of Gynecology and Obstetrics | Recruiting |
| Munich, Bavaria, Germany, 81377 | |
| Klinikum Dritter Orden | Recruiting |
| Munich, Bavaria, Germany, 80638 | |
| Rotkreuzklinikum Muenchen | Recruiting |
| Munich, Bavaria, Germany, 80634 | |
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
Additional Information:
No publications provided
| 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 |
| Study First Received: | December 20, 2010 |
| Last Updated: | December 28, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 19, 2013