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Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty

NCT ID: NCT01553097

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Neurocognitive Impairment Quality of Life

Keywords

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Breast Cancer Neurocognitive Impairment Quality of Life Cytokines

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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women with stage I or II BC with adjuvant chemotherapy

women with Stage I or II BC who

1. have undergone surgical treatment (biopsy, lumpectomy or mastectomy) and;
2. will be receiving adjuvant chemotherapy

Neurocognitive impairment observation

Intervention Type OTHER

None - observational

women with Stage I or II BC without adjuvant therapy

Women with stage I or II BC who

1. Have undergone surgical treatment (biopsy, lumpectomy or mastectomy) \\
2. will not be receiving adjuvant chemotherapy

Neurocognitive impairment observation

Intervention Type OTHER

None - observational

Healthy control

healthy education-age-matched women without cancer

Neurocognitive impairment observation

Intervention Type OTHER

None - observational

Interventions

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Neurocognitive impairment observation

None - observational

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Jo Grapp, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virnigia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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5P30NR011403

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12321

Identifier Type: -

Identifier Source: org_study_id