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Neurocognitive Impairment in Women With Early Stage Breast Cancer

21 Years
Open (Enrolling)
Breast Cancer, Neurocognitive Impairment, Quality of Life

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Trial Information

Neurocognitive Impairment in Women With Early Stage Breast Cancer

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.

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

test neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Mary Jo Grapp, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Neurocognitive Impairment
  • Quality of Life
  • Breast Cancer
  • Neurocognitive Impairment
  • Quality of Life
  • Cytokines
  • Breast Neoplasms



Virnigia Commonwealth University Richmond, Virginia  23298