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

NCT00387062 | Completed Phase 1

• 1 other identifier: OUT-113-2005; 06140-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Breast Cancer; Cognitive Symptoms; Memory Disorders

Keywords

Breast Cancer; Cognitive Impairment; Chemofog; Chemobrain; Post-chemotherapy cognitive impairment

Outcome Measures

Primary Outcomes (2)

• Examination of the quantitative training program progression data

• Safety

Secondary Outcomes (3)

• Quality of life health assessments

• Functional outcomes assessments

• Perceived stress assessments

Interventions

Computer-based Cognitive Training DEVICE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94104, United States

Location

Related Publications (23)

• 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.

  PMID: 16844416 BACKGROUND

• 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. doi: 10.1002/cncr.20393.

  PMID: 15274059 BACKGROUND

• 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. doi: 10.1200/JCO.2004.08.094.

  PMID: 15169812 BACKGROUND

• 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. doi: 10.1093/annonc/mdf241.

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• 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. doi: 10.1093/jnci/90.3.210.

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• 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. doi: 10.1002/(sici)1097-0142(19990201)85:33.0.co;2-g.

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  PMID: 15160331 BACKGROUND

• O'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.

  PMID: 14702917 BACKGROUND

• Gilbert 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.

  PMID: 11567610 BACKGROUND

• 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. doi: 10.1016/s0959-8049(03)00600-2.

  PMID: 14556919 BACKGROUND

• 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. doi: 10.1093/annonc/mdi095. Epub 2005 Jan 27.

  PMID: 15677622 BACKGROUND

• 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. doi: 10.1002/pon.964.

  PMID: 16097037 BACKGROUND

• 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. doi: 10.1200/JCO.2003.01.119.

  PMID: 14615445 BACKGROUND

• Ahles TA, Saykin A. Cognitive effects of standard-dose chemotherapy in patients with cancer. Cancer Invest. 2001;19(8):812-20. doi: 10.1081/cnv-100107743.

  PMID: 11768035 BACKGROUND

• 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. doi: 10.1016/s0885-3924(01)00268-8.

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• 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. doi: 10.1093/annonc/mdg497.

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• 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. doi: 10.1016/j.bandc.2005.05.001. Epub 2005 Jun 21.

  PMID: 15975700 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neurobehavioral Manifestations; Memory Disorders; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Henry W Mahncke, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 24, 2008

Record last verified: 2008-06

Locations

US (1)