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| ID | Type | Description | Link |
|---|---|---|---|
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| U10CA037420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties.
This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subjects with breast cancer | |||
| subjects with lymphoma | |||
| subjects without cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Short-term memory | Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task. | Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls |
| Measure | Description | Time Frame |
|---|---|---|
| Attention impairment | Change in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task. | Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls |
| Measure | Description | Time Frame |
|---|---|---|
| correlation of cognitive function with TNF alpha pathway biomarkers | serum assaying the change in the TNF pathway | change from pre to post chemotherapy and six month follow up |
Inclusion Criteria:
Subjects Receiving Chemotherapy:
Inclusion Criteria, Controls:
Inclusion Criteria, Long-Term Followup Study:
Exclusion Criteria:
Subjects Receiving Chemotherapy:
Exclusion Criteria, Controls:
Exclusion Criteria, Long-Term Followup Study:
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During enrollment, the groups will be balanced on age and gender. Controls of the same age and gender as the subject receiving chemotherapy will be enrolled at the same time.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle C. Janelsins, PhD | University of Rochester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delaware/Christiana Care NCORP | Newark | Delaware | 19713 | United States | ||
| Delaware/Christiana Care NCORP (CHRISTIANA) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35678881 | Derived | Kleckner AS, Kleckner IR, Culakova E, Shayne M, Belcher EK, Gudina AT, Williams AM, Onitilo AA, Hopkins JO, Gross H, Mustian KM, Peppone LJ, Janelsins MC. The association between cancer-related fatigue and diabetes from pre-chemotherapy to 6 months post-chemotherapy. Support Care Cancer. 2022 Sep;30(9):7655-7663. doi: 10.1007/s00520-022-07189-x. Epub 2022 Jun 9. | |
| 33546731 | Derived | Gilmore N, Mohile S, Lei L, Culakova E, Mohamed M, Magnuson A, Loh KP, Maggiore R, Belcher E, Conlin A, Weiselberg L, Ontko M, Janelsins M. The longitudinal relationship between immune cell profiles and frailty in patients with breast cancer receiving chemotherapy. Breast Cancer Res. 2021 Feb 5;23(1):19. doi: 10.1186/s13058-021-01388-w. |
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Blood
| Verbal recognition memory impairment | Change in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task. | Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls |
| Executive function impairment | Change in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task. | Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls |
| Self-report score | FACT-Cog change score | Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls |
| short term memory | Delayed match to sample score | 8 and/or 10 years post-chemotherapy |
| attention | Rapid Visual Processing speed score | 8 and/or 10 years post-chemotherapy |
| Self-report score | FACT-Cog | 8 and/or 10 years post-chemotherapy |
| Newark |
| Delaware |
| 19718 |
| United States |
| Heartland | Decatur | Illinois | 62526 | United States |
| Kansas City Clinical Oncology Program | Prairie Village | Kansas | 66208 | United States |
| Wichita NCORP | Wichita | Kansas | 67214 | United States |
| Wichita | Wichita | Kansas | 67214 | United States |
| Gulf South MU-NCORP | New Orleans | Louisiana | 70112 | United States |
| Cancer Research Consortium of West Michigan | Grand Rapids | Michigan | 49503 | United States |
| CRCWM | Grand Rapids | Michigan | 49503 | United States |
| Metro Minnesota NCORP | Minneapolis | Minnesota | 55426 | United States |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Nevada | Las Vegas | Nevada | 89106 | United States |
| Hem Onc CNY | East Syracuse | New York | 13057 | United States |
| Kansas City | Rochester | New York | 14642 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| Novant Health Cancer Institute - Kernersville | Winston-Salem | North Carolina | 27103 | United States |
| Southeast Clinical Oncology Research Program | Winston-Salem | North Carolina | 27104 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Columbus | Columbus | Ohio | 43215 | United States |
| Dayton Community Oncology Program | Dayton | Ohio | 45420 | United States |
| Dayton | Dayton | Ohio | 45459 | United States |
| Pacific Cancer Research Consortium Ncorp | Portland | Oregon | 97213 | United States |
| PCRC | Portland | Oregon | 97213 | United States |
| NCORP of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Northwest (Virginia Mason) | Seattle | Washington | 98101 | United States |
| Wisconsin NCORP | Marshfield | Wisconsin | 54449 | United States |
| Aurora NCORP | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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