Breast CancerNCT01553097
Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty
An observational study of Breast Cancer and Neurocognitive Impairment, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Neurocognitive Impairment, Quality of Life
- What is being tested?
- Neurocognitive impairment observation
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- psychiatric impairment, such as organic brain disorders, mental retardation, active psychoses or dissociative disorders, or unstable and/or severe depressive illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virnigia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Neurocognitive Impairment in Women With Early Stage Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer, Neurocognitive Impairment, Quality of Life
- Being tested
- Neurocognitive impairment observation
- Keywords
- Breast Cancer, Neurocognitive Impairment, Quality of Life, Cytokines
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive impairment observationOther
None - observational
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Neurocognitive impairment observation | |
| Healthy control | healthy education-age-matched women without cancer Receives: Other: Neurocognitive impairment observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
test neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.
Measured: baseline
test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.
Measured: 4 months
test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.
Measured: 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).
Measured: baseline, month 4 and month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Mary Jo Grapp, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553097
- Sponsor's protocol ID
- 12321
- Other IDs
- 5P30NR011403
- Status last verified
- Dec 2014
- First submitted
- 10 Nov 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Impairment in Women With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01553097
- Acronym / sponsor ID
- 12321
- Conditions
- Breast Cancer, Neurocognitive Impairment, Quality of Life
- Keywords
- Breast Cancer, Neurocognitive Impairment, Quality of Life, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| women with stage I or II BC with adjuvant chemotherapy | – | Other: Neurocognitive impairment observationwomen with Stage I or II BC who 1. have undergone surgical treatment (biopsy, lumpectomy or mastectomy) and; 2. will be receiving adjuvant chemotherapy |
| women with Stage I or II BC without adjuvant therapy | – | Other: Neurocognitive impairment observationWomen with stage I or II BC who 1. Have undergone surgical treatment (biopsy, lumpectomy or mastectomy) \ 2. will not be receiving adjuvant chemotherapy |
| Healthy control | – | Other: Neurocognitive impairment observationhealthy education-age-matched women without cancer |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- psychiatric impairment, such as organic brain disorders, mental retardation, active psychoses or dissociative disorders, or unstable and/or severe depressive illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive impairment observationNone - observational | Other | Healthy control, women with Stage I or II BC without adjuvant therapy, women with stage I or II BC with adjuvant chemotherapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jo Grapp, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Neurocognitive Impairment, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
test neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms. (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.