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Completed

NCT Number: NCT01264562

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Frauenklinik des Helios Amper Klinikums Dachau, Dachau, Bavaria, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Course of cognitive function

    Time frame: 12 months

    Performance on a battery of cognitive tests

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Acronym: Cognicares

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2010
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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