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The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Survivor (BCS) | Enrolled participants will be asked to complete a one-time, remote neurocognitive assessment. The neurocognitive assessment will consist of the CogSuite Neurocognitive Battery, an online, remotely deliverable battery of cognitive experimental measures, and a standard battery of remote neuropsychological measures. DNA will be collected via mailed saliva kits to assess Apolipoprotein E (APOE) status. |
| |
| Non-cancer Control (NCC) | Enrolled participants will be asked to complete a one-time, remote neurocognitive assessment. The neurocognitive assessment will consist of the CogSuite Neurocognitive Battery, an online, remotely deliverable battery of cognitive experimental measures, and a standard battery of remote neuropsychological measures. DNA will be collected via mailed saliva kits to assess Apolipoprotein E (APOE) status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessments | Other | Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| examine cognitive effects | of remote cancer diagnosis and treatment and potential association with increased/accelerated deficit accumulation in older survivors.The primary outcome is cognitive performance, as measured by CogSuite aggregate intra-individual variability, the average intra-individual variability across the subtests. Cognition will be assessed using the CogSuite battery of five subtests: 1) Attention Network Test; 2) Mental Rotation; 3) Stop Signal Delay; 4) N-back; and 5) Psychomotor Speed measures. | within 45 days of participant consent |
| Measure | Description | Time Frame |
|---|---|---|
| measure levels of smoking exposure | by testing cotinine (an important metabolite of nicotine) in urine samples to examine possible interactions of smoking history with genetic variants, e.g., APOE ε4+, on cognition | within 45 days of participant consent |
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Inclusion Criteria:
All Participants:
Breast Cancer Survivors:
Non-Cancer Controls:
Per self-report, no history of breast cancer
Language verification: For both survivors and controls, prior to enrollment, all will be asked the following two questions by a CRC to verify English fluency necessary for participation in the study:
Exclusion Criteria:
All participants:
Breast Cancer Survivors:
Non-Cancer Controls:
Breast Cancer
Survivors will be recruited in Breast Medicine Service clinics at the Breast and Imaging Center (BAIC) after having been identified via a Dataline query and/or weekly clinic schedules or through direct referrals from a member of the patient's treatment team.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Root, PhD | Contact | 646-888-0035 | rootj@mskcc.org | |
| Denise Correa, PhD | Contact | 212-610-0491 |
| Name | Affiliation | Role |
|---|---|---|
| James Root, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Salvia, Urine
| Assessment (Survivors Only) | Other | *Tumor/Treatment Variables (Survivors Only) |
|
| APOE and DNA Isolation | Other | Biospecimens procurement and processing |
|
| Memorial Sloan Kettering Monmouth (All protocol activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Uniondale | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D001057 | Apolipoproteins E |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D001053 | Apolipoproteins |
| D008074 | Lipoproteins |
| D008055 | Lipids |
| D001059 | Apoproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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