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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01264562

Acronym

Cognicares

Enrollment

254

Registered

2010-12-22

Start date

2011-01-31

Completion date

2014-10-31

Last updated

2016-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Course of cognitive function	12 months	Performance on a battery of cognitive tests

Secondary

Measure	Time frame	Description
Course of the stress response	12 months	Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
Course of subjective cognitive function	12 months	Self-reported cognitive problems
Course of the HPA-axis function	12 months	Cortisol awakening response and diurnal profile

Countries

Germany

Outcome results