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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01553097
First received: November 10, 2011
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Neurocognitive Impairment
Quality of Life
Other: Neurocognitive impairment observation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neurocognitive Impairment in Women With Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • test neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms. [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

3 cc of blood in a BD Vacutainer® tube preserved with 5.4mg K2 EDTA for the cytokine assay


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Neurocognitive impairment observation
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
Other: Neurocognitive impairment observation
None - observational
Healthy control
healthy education-age-matched women without cancer
Other: Neurocognitive impairment observation
None - observational

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants in the two BC groups will be recruited from the Massey Cancer Center (MCC) clinical sites in Richmond, VA. Healthy volunteers will be recruited throughout the VCU Health System and through women's groups throughout the greater Richmond, VA area. The PI will provide physicians and clinical nurses an overview of the research and work with them to identify potential project participants. Participants will be provided oral and written information about the research and given an opportunity to ask questions or discuss the project with family or significant others.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553097

Locations
United States, Virginia
Virnigia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Mary Jo Grapp, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01553097     History of Changes
Other Study ID Numbers: 12321, 5P30NR011403
Study First Received: November 10, 2011
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Breast Cancer
Neurocognitive Impairment
Quality of Life
Cytokines

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014