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


N/A
18 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Course of cognitive function

Outcome Description:

Performance on a battery of cognitive tests

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Kerstin Hermelink, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ludwig Maximilian University, Department of Gynecology and Obstetrics

Authority:

Germany: Ethics Commission

Study ID:

DKH 109132

NCT ID:

NCT01264562

Start Date:

January 2011

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • chemotherapy, adjuvant
  • adverse effects
  • breast neoplasms
  • cognition disorders
  • Stress Disorders, post-traumatic
  • cortisol
  • Breast Neoplasms

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