Breast CancerPhase 1NCT00387062
Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment
A Phase 1 study testing Computer-based Cognitive Training in people with Breast Cancer and Cognitive Symptoms, run by Posit Science Corporation at 1 site in United States.
Trial summary
The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory and cognitive functioning in patients suffering from "chemobrain". Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Cognitive Symptoms, Memory Disorders
- What is being tested?
- Computer-based Cognitive Training
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2008
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 or older at the time of consent.
- Diagnosis of invasive breast cancer or recurrence warranting treatment with chemotherapeutic agents in the past 5 years.
- Cognitive decline, as reported by the patient, friends, or family.
- Fluent English speaker.
- Willing and able to commit to the 6-month time requirement of the entire study period.
- Willing to provide informed consent
- Willing to participate in training of the program.
- Agrees to weekly contact
Who cannot join
- Severe hearing impairments that would:
- limit the ability to receive instructions and support; and
- hinder performance on the computer training program.
- Self-report of untreated Axis I or II disorders (with the exception of depression, anxiety disorders, and panic disorders).
- Self-report of current diagnosis or history of major neurological illness including, but not limited to:
- Alzheimer's disease
Show all 13Show fewer
- Parkinson's disease
- Multiple sclerosis
- Amyotrophic lateral sclerosis
- History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems.
- Self-report of fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device.
- Unwillingness to complete the required assessments.
- Patient is not capable of giving informed consent or unable to comprehend and/or follow instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94104
About this study
Official title: Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study
The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory and cognitive functioning in patients suffering from "chemobrain".
Read the detailed description
Breast cancer is the most common malignancy in women in the United States, with an estimated 211,240 new cases of invasive breast cancer diagnosed among women, and 1,700 diagnosed in men, in 2005. While cure rates have improved significantly, chemotherapy for breast cancer is associated with a number of negative side effects. One of which is a deficit in cognitive function, a condition commonly referred to as "chemobrain". While the debate about cognitive decline being a result of chemotherapy is still ongoing, there is clear evidence of cognitive decline in women with breast cancer post-chemotherapy. Cognitive decline is often reported to affect memory, attention, executive functioning and information processing speed.
Studies suggest that incidence of "chemobrain" ranges from 17% - 75% in women who have undergone chemotherapy.This cognitive impairment affects quality of life by impacting patients' ability to concentrate, make decisions and to fulfill family, career, and community responsibilities.
Although there is uncertainty about the mechanisms that can lead to this cognitive decline, there is a pressing need to identify interventions that will alleviate its symptoms and help breast cancer survivors recover their cognitive functioning and resume their roles and activities at the pre-cancer level.
Brain plasticity refers to the brain's capacity for physical and functional change; it is this capacity that explains how experience induces learning throughout life. On the basis of a growing body of literature in the fields of psychophysics, neurology, neuropsychology, and brain plasticity, we hypothesize that the brain processing machinery can be refined, elaborated, and strengthened through rigorous training and learning. The purpose of this study is to investigate if such training can improve cognitive functioning.
We hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance will help improve memory and cognitive functioning in patients suffering from "chemobrain".
- Conditions
- Breast Cancer, Cognitive Symptoms, Memory Disorders
- Being tested
- Computer-based Cognitive Training
- Keywords
- Breast Cancer, Cognitive Impairment, Chemofog, Chemobrain, Post-chemotherapy cognitive impairment
- Medical subject headings
- Breast Neoplasms, Neurobehavioral Manifestations, Memory Disorders, Cognitive Dysfunction, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based Cognitive TrainingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of the quantitative training program progression data
Safety
Secondary outcomes (3)
Quality of life health assessments
Functional outcomes assessments
Perceived stress assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry W Mahncke, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387062
- Sponsor's protocol ID
- OUT-113-2005; 06140-01
- Status last verified
- Jun 2008
- First submitted
- 10 Oct 2006
- Last updated
- 24 Jun 2008
- Results posted
- No
Publications
Shilling V, Jenkins V. Self-reported cognitive problems in women receiving adjuvant therapy for breast cancer. Eur J Oncol Nurs. 2007 Feb;11(1):6-15. doi: 10.1016/j.ejon.2006.02.005. Epub 2006 Jul 17.
PubMed 16844416Wefel JS, Lenzi R, Theriault R, Buzdar AU, Cruickshank S, Meyers CA. 'Chemobrain' in breast carcinoma?: a prologue. Cancer. 2004 Aug 1;101(3):466-75. doi: 10.1002/cncr.20393.
PubMed 15274059Tannock IF, Ahles TA, Ganz PA, Van Dam FS. Cognitive impairment associated with chemotherapy for cancer: report of a workshop. J Clin Oncol. 2004 Jun 1;22(11):2233-9. doi: 10.1200/JCO.2004.08.094.
PubMed 15169812Schagen SB, Muller MJ, Boogerd W, Rosenbrand RM, van Rhijn D, Rodenhuis S, van Dam FS. Late effects of adjuvant chemotherapy on cognitive function: a follow-up study in breast cancer patients. Ann Oncol. 2002 Sep;13(9):1387-97. doi: 10.1093/annonc/mdf241.
PubMed 12196364van Dam FS, Schagen SB, Muller MJ, Boogerd W, vd Wall E, Droogleever Fortuyn ME, Rodenhuis S. Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy. J Natl Cancer Inst. 1998 Feb 4;90(3):210-8. doi: 10.1093/jnci/90.3.210.
PubMed 9462678Schagen SB, van Dam FS, Muller MJ, Boogerd W, Lindeboom J, Bruning PF. Cognitive deficits after postoperative adjuvant chemotherapy for breast carcinoma. Cancer. 1999 Feb 1;85(3):640-50. doi: 10.1002/(sici)1097-0142(19990201)85:33.0.co;2-g.
PubMed 10091737Brezden CB, Phillips KA, Abdolell M, Bunston T, Tannock IF. Cognitive function in breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2000 Jul;18(14):2695-701. doi: 10.1200/JCO.2000.18.14.2695.
PubMed 10894868Jansen CE, Miaskowski C, Dodd M, Dowling G. Chemotherapy-induced cognitive impairment in women with breast cancer: a critique of the literature. Oncol Nurs Forum. 2005 Mar 5;32(2):329-42. doi: 10.1188/05.ONF.329-342.
PubMed 15759070Paraska K, Bender CM. Cognitive dysfunction following adjuvant chemotherapy for breast cancer: two case studies. Oncol Nurs Forum. 2003 May-Jun;30(3):473-8. doi: 10.1188/03.ONF.473-478.
PubMed 12719746Wefel JS, Lenzi R, Theriault RL, Davis RN, Meyers CA. The cognitive sequelae of standard-dose adjuvant chemotherapy in women with breast carcinoma: results of a prospective, randomized, longitudinal trial. Cancer. 2004 Jun 1;100(11):2292-9. doi: 10.1002/cncr.20272.
PubMed 15160331O'Shaughnessy J. Chemotherapy-related cognitive dysfunction in breast cancer. Semin Oncol Nurs. 2003 Nov;19(4 Suppl 2):17-24. doi: 10.1053/j.soncn.2003.09.002.
PubMed 14702917Gilbert CD, Sigman M, Crist RE. The neural basis of perceptual learning. Neuron. 2001 Sep 13;31(5):681-97. doi: 10.1016/s0896-6273(01)00424-x.
PubMed 11567610Morse R, Rodgers J, Verrill M, Kendell K. Neuropsychological functioning following systemic treatment in women treated for breast cancer: a review. Eur J Cancer. 2003 Nov;39(16):2288-97. doi: 10.1016/s0959-8049(03)00600-2.
PubMed 14556919de Jong N, Candel MJ, Schouten HC, Abu-Saad HH, Courtens AM. Course of mental fatigue and motivation in breast cancer patients receiving adjuvant chemotherapy. Ann Oncol. 2005 Mar;16(3):372-82. doi: 10.1093/annonc/mdi095. Epub 2005 Jan 27.
PubMed 15677622Bender CM, Sereika SM, Berga SL, Vogel VG, Brufsky AM, Paraska KK, Ryan CM. Cognitive impairment associated with adjuvant therapy in breast cancer. Psychooncology. 2006 May;15(5):422-30. doi: 10.1002/pon.964.
PubMed 16097037
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study
- ClinicalTrials.gov ID
- NCT00387062
- Acronym / sponsor ID
- OUT-113-2005; 06140-01
- Conditions
- Breast Cancer, Cognitive Symptoms, Memory Disorders
- Keywords
- Breast Cancer, Cognitive Impairment, Chemofog, Chemobrain, Post-chemotherapy cognitive impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Oct 2006 (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.
The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory and cognitive functioning in patients suffering from "chemobrain".
Detailed description
Breast cancer is the most common malignancy in women in the United States, with an estimated 211,240 new cases of invasive breast cancer diagnosed among women, and 1,700 diagnosed in men, in 2005. While cure rates have improved significantly, chemotherapy for breast cancer is associated with a number of negative side effects. One of which is a deficit in cognitive function, a condition commonly referred to as "chemobrain". While the debate about cognitive decline being a result of chemotherapy is still ongoing, there is clear evidence of cognitive decline in women with breast cancer post-chemotherapy. Cognitive decline is often reported to affect memory, attention, executive functioning and information processing speed.
Studies suggest that incidence of "chemobrain" ranges from 17% - 75% in women who have undergone chemotherapy.This cognitive impairment affects quality of life by impacting patients' ability to concentrate, make decisions and to fulfill family, career, and community responsibilities.
Although there is uncertainty about the mechanisms that can lead to this cognitive decline, there is a pressing need to identify interventions that will alleviate its symptoms and help breast cancer survivors recover their cognitive functioning and resume their roles and activities at the pre-cancer level.
Brain plasticity refers to the brain's capacity for physical and functional change; it is this capacity that explains how experience induces learning throughout life. On the basis of a growing body of literature in the fields of psychophysics, neurology, neuropsychology, and brain plasticity, we hypothesize that the brain processing machinery can be refined, elaborated, and strengthened through rigorous training and learning. The purpose of this study is to investigate if such training can improve cognitive functioning.
We hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance will help improve memory and cognitive functioning in patients suffering from "chemobrain".
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21 or older at the time of consent.
- Diagnosis of invasive breast cancer or recurrence warranting treatment with chemotherapeutic agents in the past 5 years.
- Cognitive decline, as reported by the patient, friends, or family.
- Fluent English speaker.
- Willing and able to commit to the 6-month time requirement of the entire study period.
Key exclusion criteria (13 listed)
- Severe hearing impairments that would:
- Self-report of untreated Axis I or II disorders (with the exception of depression, anxiety disorders, and panic disorders).
- Self-report of current diagnosis or history of major neurological illness including, but not limited to:
- History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems.
- Self-report of fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device.
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 |
|---|---|---|
| Computer-based Cognitive Training | Device | – |
Primary outcome
Examination of the quantitative training program progression data
Safety
3 secondary outcomes
Quality of life health assessments
Functional outcomes assessments
Perceived stress assessments
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 24 Jun 2008.
- Background: PubMed 16844416Shilling V, Jenkins V. Self-reported cognitive problems in women receiving adjuvant therapy for breast cancer. Eur J Oncol Nurs. 2007 Feb;11(1):6-15. doi: 10.1016/j.ejon.2006.02.005. Epub 2006 Jul 17.
- Background: PubMed 15274059Wefel JS, Lenzi R, Theriault R, Buzdar AU, Cruickshank S, Meyers CA. 'Chemobrain' in breast carcinoma?: a prologue. Cancer. 2004 Aug 1;101(3):466-75. doi: 10.1002/cncr.20393.
- Background: PubMed 15169812Tannock IF, Ahles TA, Ganz PA, Van Dam FS. Cognitive impairment associated with chemotherapy for cancer: report of a workshop. J Clin Oncol. 2004 Jun 1;22(11):2233-9. doi: 10.1200/JCO.2004.08.094.
- Background: PubMed 12196364Schagen SB, Muller MJ, Boogerd W, Rosenbrand RM, van Rhijn D, Rodenhuis S, van Dam FS. Late effects of adjuvant chemotherapy on cognitive function: a follow-up study in breast cancer patients. Ann Oncol. 2002 Sep;13(9):1387-97. doi: 10.1093/annonc/mdf241.
- Background: PubMed 9462678van Dam FS, Schagen SB, Muller MJ, Boogerd W, vd Wall E, Droogleever Fortuyn ME, Rodenhuis S. Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy. J Natl Cancer Inst. 1998 Feb 4;90(3):210-8. doi: 10.1093/jnci/90.3.210.
- Background: PubMed 10091737Schagen SB, van Dam FS, Muller MJ, Boogerd W, Lindeboom J, Bruning PF. Cognitive deficits after postoperative adjuvant chemotherapy for breast carcinoma. Cancer. 1999 Feb 1;85(3):640-50. doi: 10.1002/(sici)1097-0142(19990201)85:33.0.co;2-g.
- Background: PubMed 10894868Brezden CB, Phillips KA, Abdolell M, Bunston T, Tannock IF. Cognitive function in breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2000 Jul;18(14):2695-701. doi: 10.1200/JCO.2000.18.14.2695.
- Background: PubMed 15759070Jansen CE, Miaskowski C, Dodd M, Dowling G. Chemotherapy-induced cognitive impairment in women with breast cancer: a critique of the literature. Oncol Nurs Forum. 2005 Mar 5;32(2):329-42. doi: 10.1188/05.ONF.329-342.
- Background: PubMed 12719746Paraska K, Bender CM. Cognitive dysfunction following adjuvant chemotherapy for breast cancer: two case studies. Oncol Nurs Forum. 2003 May-Jun;30(3):473-8. doi: 10.1188/03.ONF.473-478.
- Background: PubMed 15160331Wefel JS, Lenzi R, Theriault RL, Davis RN, Meyers CA. The cognitive sequelae of standard-dose adjuvant chemotherapy in women with breast carcinoma: results of a prospective, randomized, longitudinal trial. Cancer. 2004 Jun 1;100(11):2292-9. doi: 10.1002/cncr.20272.
- Background: PubMed 14702917O'Shaughnessy J. Chemotherapy-related cognitive dysfunction in breast cancer. Semin Oncol Nurs. 2003 Nov;19(4 Suppl 2):17-24. doi: 10.1053/j.soncn.2003.09.002.
- Background: PubMed 11567610Gilbert CD, Sigman M, Crist RE. The neural basis of perceptual learning. Neuron. 2001 Sep 13;31(5):681-97. doi: 10.1016/s0896-6273(01)00424-x.
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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.
Henry W Mahncke, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer-based Cognitive Training in people with Breast Cancer and Cognitive Symptoms, run by Posit Science Corporation 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 8 inclusion and 13 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 24 Jun 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Examination of the quantitative training program progression data. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00387062, which also lists 23 linked publications.
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 24 Jun 2008; AzTrials last refreshed its copy on 1 Nov 2026.