A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC)

Официальное название

Cognitive Aging in Older Long-term Breast Cancer Survivors

Обзор

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.

Вмешательства

• Другое Assessments
  Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment
• Другое Assessment (Survivors Only)
  \*Tumor/Treatment Variables (Survivors Only)
• Другое APOE and DNA Isolation
  Biospecimens procurement and processing

Первичные конечные точки

• examine cognitive effects [Срок оценки: within 45 days of participant consent]

Вторичные конечные точки (1)

• measure levels of smoking exposure [Срок оценки: within 45 days of participant consent]

Критерии участия

Критерии включения

All Participants:

• Per medical record and/or self-report, identifies as female
• Per medical record and/or self-report, currently age 60-80
• Per self-report, has access to a computer and internet connectivity
• Score of <11 on Blessed Orientation-Memory-Concentration Test (BOMC)
• As per medical record or self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment.
• English fluent (as per self-report, fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff)\*\*

Breast Cancer Survivors:

• Per medical record and/or self-report, history of stage 0-3 breast cancer diagnosed between 50-60 years of age
• Per medical record and/or self-report, no evidence of disease (NED)

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:

• How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
• What is your preferred language for healthcare? (must respond English)

Критерии исключения

All participants:

• As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)
• As per medical record or self-report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation
• As per medical record or self-report, a diagnosis of a major Axis I psychiatric disorder including Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
• As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)
• As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for lupus.
• As per medical record or self-report, participation in a conflicting (overlapping neurocognitive assessments) research study (i.e. MSK 18-294)

Breast Cancer Survivors:

• As per medical record or self-report, history of cancer recurrence
• As per medical record or self-report, any history of another cancer except nonmelanoma skin cancer or first breast cancer (a secondary breast cancer is exclusionary)
• As per medical record or self-report, breast cancer only treated with surgery

Non-Cancer Controls:

• As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
• As per medical record or self-report, any history of cancer except non-melanoma skin cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 7 центров

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center — New York
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT06334354 · 23-320

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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