Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment

Breast Cancer Clinical Trial

Official title:

Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387062
• Other study ID #: OUT-113-2005; 06140-01
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2006
• Last updated: June 23, 2008
• Start date: October 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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".

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Cognition Disorders
• Cognitive Symptoms
• Memory Disorders
• Neurobehavioral Manifestations

Intervention

Device:
• Computer-based Cognitive Training

Locations

Country	Name	City	State
United States	Posit Science Corporation	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Posit Science Corporation

Country where clinical trial is conducted

United States, 

References & Publications (23)

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Bender CM, Paraska KK, Sereika SM, Ryan CM, Berga SL. Cognitive function and reproductive hormones in adjuvant therapy for breast cancer: a critical review. J Pain Symptom Manage. 2001 May;21(5):407-24. Review. — View Citation

Bender 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. — View Citation

Brezden 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. — View Citation

Cimprich B, So H, Ronis DL, Trask C. Pre-treatment factors related to cognitive functioning in women newly diagnosed with breast cancer. Psychooncology. 2005 Jan;14(1):70-8. — View Citation

de 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. Epub 2005 Jan 27. — View Citation

Falleti MG, Sanfilippo A, Maruff P, Weih L, Phillips KA. The nature and severity of cognitive impairment associated with adjuvant chemotherapy in women with breast cancer: a meta-analysis of the current literature. Brain Cogn. 2005 Oct;59(1):60-70. Epub 2005 Jun 21. Review. — View Citation

Gilbert CD, Sigman M, Crist RE. The neural basis of perceptual learning. Neuron. 2001 Sep 13;31(5):681-97. Review. — View Citation

Jansen CE, Miaskowski C, Dodd M, Dowling G, Kramer J. A metaanalysis of studies of the effects of cancer chemotherapy on various domains of cognitive function. Cancer. 2005 Nov 15;104(10):2222-33. — View Citation

Jansen 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. Review. — View Citation

Morse 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. Review. — View Citation

O'Shaughnessy J. Chemotherapy-related cognitive dysfunction in breast cancer. Semin Oncol Nurs. 2003 Nov;19(4 Suppl 2):17-24. Review. — View Citation

Paraska K, Bender CM. Cognitive dysfunction following adjuvant chemotherapy for breast cancer: two case studies. Oncol Nurs Forum. 2003 May-Jun;30(3):473-8. — View Citation

Phillips KA, Bernhard J. Adjuvant breast cancer treatment and cognitive function: current knowledge and research directions. J Natl Cancer Inst. 2003 Feb 5;95(3):190-7. Review. — View Citation

Schagen 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. — View Citation

Schagen 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. — View Citation

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. Epub 2006 Jul 17. — View Citation

Tannock 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. Review. — View Citation

Tchen N, Juffs HG, Downie FP, Yi QL, Hu H, Chemerynsky I, Clemons M, Crump M, Goss PE, Warr D, Tweedale ME, Tannock IF. Cognitive function, fatigue, and menopausal symptoms in women receiving adjuvant chemotherapy for breast cancer. J Clin Oncol. 2003 Nov 15;21(22):4175-83. — View Citation

van 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. — View Citation

Watters JM, Yau JC, O'Rourke K, Tomiak E, Gertler SZ. Functional status is well maintained in older women during adjuvant chemotherapy for breast cancer. Ann Oncol. 2003 Dec;14(12):1744-50. — View Citation

Wefel 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. — View Citation

Wefel 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the quantitative training program progression data
Primary	Safety
Secondary	Quality of life health assessments
Secondary	Functional outcomes assessments
Secondary	Perceived stress assessments