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

NCT01553097 | Completed DMC

• 2 other identifiers: 123215P30NR011403
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Neurocognitive Impairment; Quality of Life

Keywords

Breast Cancer; Neurocognitive Impairment; Quality of Life; Cytokines

Outcome Measures

Primary Outcomes (3)

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

  baseline

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

  4 months

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

  9 months

Secondary Outcomes (1)

• 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).

  baseline, month 4 and month 9

Study Arms (3)

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

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

Healthy control

healthy education-age-matched women without cancer

Other: Neurocognitive impairment observation

Interventions

Neurocognitive impairment observation OTHER

None - observational

Healthy control; women with Stage I or II BC without adjuvant therapy; women with stage I or II BC with adjuvant chemotherapy

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• psychiatric impairment, such as organic brain disorders, mental retardation, active psychoses or dissociative disorders, or unstable and/or severe depressive illness.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Virnigia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary Jo Grapp, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)