Overview

This trial is active, not recruiting.

Conditions breast cancer, neurocognitive impairment, quality of life
Treatment neurocognitive impairment observation
Sponsor Virginia Commonwealth University
Collaborator National Institute of Nursing Research (NINR)
Start date March 2012
End date May 2014
Trial size 100 participants
Trial identifier NCT01553097, 12321, 5P30NR011403

Summary

This longitudinal project will investigate a common complaint of women who receive chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress, and depression to cognitive difficulties will be examined. The findings should lead to interventions to decrease the effects of these problematic side effects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
women with Stage I or II BC who have undergone surgical treatment (biopsy, lumpectomy or mastectomy) and; will be receiving adjuvant chemotherapy
neurocognitive impairment observation
None - observational
Women with stage I or II BC who Have undergone surgical treatment (biopsy, lumpectomy or mastectomy) \ will not be receiving adjuvant chemotherapy
neurocognitive impairment observation
None - observational
healthy education-age-matched women without cancer
neurocognitive impairment observation
None - observational

Primary Outcomes

Measure
test neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.
time frame: baseline
test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.
time frame: 4 months
test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.
time frame: 9 months

Secondary Outcomes

Measure
test level of inflammatory markers in order to explore the relationships between key behavioral and biological markers that may explain underlying mechanisms for development of neurocognitive impairment (NI).
time frame: baseline, month 4 and month 9

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - read and speak English - be physically able to take the computerized test (press the keyboard space bar and numerical keys "1" and "2" without difficulty) - have an ECOG Performance Status score < 2.154 - capable of providing informed consent. Exclusion Criteria: - psychiatric impairment, such as organic brain disorders, mental retardation, active psychoses or dissociative disorders, or unstable and/or severe depressive illness.

Additional Information

Official title Neurocognitive Impairment in Women With Early Stage Breast Cancer
Principal investigator Mary Jo Grapp, PhD
Description Most women with breast cancer are diagnosed in the early stages of the disease (Stage I and II) and 90% of these can expect to survive at least 5 years. Adjuvant chemotherapy regimens for breast cancer are often associated with complaints of cognitive changes, mostly the inability to concentrate and memory lapses that may persist in some women long after chemotherapy has ended. These changes are frequently accompanied by reports of a triad of behavioral conditions: fatigue, increased stress, and depressive symptoms. Biologically, cytokine release patterns play an important role in regulation of the immune system and normal CNS function, including neural cell repair and metabolism of neurotransmitters—both critical for normal cognitive functioning. Thus, the theoretical underpinnings of this research are embedded in the biobehavioral (mind-body) model which characterizes the multidimensional interactions among the mind, neuroendocrine, and immune systems. The purpose of this prospective, longitudinal project of 100 women is to determine whether there are differences in cognitive functioning and related behavioral conditions (fatigue, perceived stress, and depressive symptoms) in women in each of 3 groups: those with early stage BC treated with surgery and chemotherapy, women with early stage BC treated with surgery and without chemotherapy and an age-gender-education-matched healthy cohort without cancer. The primary aim of the project is to examine the relationships among fatigue, perceived stress, and depressive symptoms and neurocognitive impairment. A secondary aim is to explore the relationships among key behavioral and biological markers that may explain underlying mechanisms for development of neurocognitive impairment. In particular, this project will explore pro- and anti-inflammatory cytokine patterns and their potential associations with neurocognitive functioning. For the primary aim, the mixed linear model will be used to test for differences between the groups. For analysis of the secondary aim variable reduction stage and correlation will be used. The strength of this project is its biobehavioral approach to discerning underlying mechanisms of neurocognitive impairment in women with early stage BC receiving adjuvant chemotherapy. In addition, three other common behavioral conditions associated with BC and/or chemotherapy, fatigue, perceived stress, and depressive symptoms, will be evaluated for their potentially confounding effects on cognitive function.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.