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| Name | Class |
|---|---|
| Shirley Ryan AbilityLab | OTHER |
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The primary purpose of this study is to test the effects of a targeted, computerized cognitive training program on verbal memory in older women who have undergone chemotherapy treatment for early-stage breast cancer. As measured by neuropsychological assessment, this treatment will result in improved verbal memory. Secondarily, processing speed and naming abilities are expected to improve. Enhanced self-perception of cognitive ability is also expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized cognitive treatment | Experimental | Chosen exercises from the rehabilitation package of a commercially available, computerized, cognitive training program called Happy Neuron Pro will be used. This program was designed by a team of neurologists, neuropsychologists and cognitive psychologists, and has been successfully adapted for varying conditions of cognitive dysfunction. |
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| Wait list control | No Intervention | Participants assigned to the wait list control arm will receive no treatment while the experimental arm is participating in the computerized treatment. However, the computerized treatment program will be made available for these participants to utilize at the end of the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized cognitive treatment | Behavioral | Participants will engage in auditory and verbal memory exercises intended to improve verbal memory functioning. The exercises are: Elephant Memory, Words where are you?, Split words, Bird Songs, Sound check, and You've got voicemail. Participants will complete the exercises 1 hour per day, 6 days per week, for 6 weeks. The program automatically adjusts difficulty level according to individual performance. The program captures and reports all relevant data to the primary investigator, including accuracy and reaction time (speed), which will be used to measure progress. |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Memory | Immediate and delayed verbal memory | Change in Verbal Memory scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Processing Speed measured via Lexical Decision Task | The Lexical Decision Task is a computerized task that measures processing speed by calculating reaction times to verb and non-verb stimuli. Outcome is measured by reaction time in milliseconds. | Change in Processing Speed scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Functional Assessment of Cancer Therapy-Cognition | Self-perception of cognitive ability | Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks |
| Treatment satisfaction survey | Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane F Morean, PhD | Northwestern University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Cancer Society (2014). Cancer prevalence: How many people have cancer? Retrieved March 24, 2015 from http://www.cancer.org/cancer/cancerbasics/cancer-prevalence. | ||
| 19403884 | Background | McKoy JM, Samaras AT, Bennett CL. Providing cancer care to a graying and diverse cancer population in the 21st century: are we prepared? J Clin Oncol. 2009 Jun 10;27(17):2745-6. doi: 10.1200/JCO.2009.22.4352. Epub 2009 Apr 29. No abstract available. | |
| 19403886 |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Processing Speed measured via Stroop Color-Word Test | The Stroop Color-Word task is a paper and pencil task that measures processing speed by assessing correct number of words read, correct number of color names read, and correct number of color-word interference pairs (i.e., names of colors printed in non-matching ink colors) read in 45 seconds. Outcomes are measured in raw scores and associated T-scores referenced against sex+age normative groups. The Stroop Color-Word Test scores will not be aggregated with the Lexical Decision Task scores. | Change in Processing Speed scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks |
| Background |
| Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009 Jun 10;27(17):2758-65. doi: 10.1200/JCO.2008.20.8983. Epub 2009 Apr 29. |
| 22918524 | Background | Von Ah D, Carpenter JS, Saykin A, Monahan P, Wu J, Yu M, Rebok G, Ball K, Schneider B, Weaver M, Tallman E, Unverzagt F. Advanced cognitive training for breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat. 2012 Oct;135(3):799-809. doi: 10.1007/s10549-012-2210-6. Epub 2012 Aug 24. |
| 19337933 | Background | Poppelreuter M, Weis J, Bartsch HH. Effects of specific neuropsychological training programs for breast cancer patients after adjuvant chemotherapy. J Psychosoc Oncol. 2009;27(2):274-96. doi: 10.1080/07347330902776044. |
| 23647804 | Background | Kesler S, Hadi Hosseini SM, Heckler C, Janelsins M, Palesh O, Mustian K, Morrow G. Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Clin Breast Cancer. 2013 Aug;13(4):299-306. doi: 10.1016/j.clbc.2013.02.004. Epub 2013 May 4. |
| 23955490 | Background | Ercoli LM, Castellon SA, Hunter AM, Kwan L, Kahn-Mills BA, Cernin PA, Leuchter AF, Ganz PA. Assessment of the feasibility of a rehabilitation intervention program for breast cancer survivors with cognitive complaints. Brain Imaging Behav. 2013 Dec;7(4):543-53. doi: 10.1007/s11682-013-9237-0. |
| 17152119 | Background | Ferguson RJ, Ahles TA, Saykin AJ, McDonald BC, Furstenberg CT, Cole BF, Mott LA. Cognitive-behavioral management of chemotherapy-related cognitive change. Psychooncology. 2007 Aug;16(8):772-7. doi: 10.1002/pon.1133. |
| 22271538 | Background | Ferguson RJ, McDonald BC, Rocque MA, Furstenberg CT, Horrigan S, Ahles TA, Saykin AJ. Development of CBT for chemotherapy-related cognitive change: results of a waitlist control trial. Psychooncology. 2012 Feb;21(2):176-86. doi: 10.1002/pon.1878. Epub 2010 Dec 2. |
| 24713425 | Background | Lange M, Rigal O, Clarisse B, Giffard B, Sevin E, Barillet M, Eustache F, Joly F. Cognitive dysfunctions in elderly cancer patients: a new challenge for oncologists. Cancer Treat Rev. 2014 Jul;40(6):810-7. doi: 10.1016/j.ctrv.2014.03.003. Epub 2014 Mar 20. |
| 14745746 | Background | Jenkins V, Shilling V, Fallowfield L, Howell A, Hutton S. Does hormone therapy for the treatment of breast cancer have a detrimental effect on memory and cognition? A pilot study. Psychooncology. 2004 Jan;13(1):61-6. doi: 10.1002/pon.709. |
| 24453297 | Background | McKoy JM, Burhenn PS, Browner IS, Loeser KL, Tulas KM, Oden MR, Rupper RW. Assessing cognitive function and capacity in older adults with cancer. J Natl Compr Canc Netw. 2014 Jan;12(1):138-44. doi: 10.6004/jnccn.2014.0011. |
| 22792378 | Background | Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11. |
| 23780693 | Background | Maseda A, Millan-Calenti JC, Lorenzo-Lopez L, Nunez-Naveira L. Efficacy of a computerized cognitive training application for older adults with and without memory impairments. Aging Clin Exp Res. 2013 Aug;25(4):411-9. doi: 10.1007/s40520-013-0070-5. Epub 2013 Jun 19. |
| 12775401 | Background | Gunther VK, Schafer P, Holzner BJ, Kemmler GW. Long-term improvements in cognitive performance through computer-assisted cognitive training: a pilot study in a residential home for older people. Aging Ment Health. 2003 May;7(3):200-6. doi: 10.1080/1360786031000101175. |
| Background | Smith, A. (2014). Older adults and technology use. Pew Research Center. Retrieved on March 24, 2015 from http://www.pewinternet.org/2014/04/03/older-adults-and-technology-use/. |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |