Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Scores of the Self-Administered Gerocognitive Exam (SAGE)
研究概览
简要总结
The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.
详细描述
The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma
- •Patients who will undergo pre-transplant evaluation with intentions to proceed to autologous stem cell transplant after stem cell collection.
- •Patients willing and able to understand and sign an informed consent form
- •Patients 18 yrs of age or older
排除标准
- •Patients with unstable psychiatric illness within the past 3 months of study enrollment.
- •Patients who are considered unable to perform study evaluations at the investigator's discretion.
- •Patients who are unable to read. (If patients require reading glasses, they must be worn at time of test.)
- •Patients who do not proceed to stem cell transplant within 60 days of stem cell collection will be excluded from study.
- •Patients who receive more than one cycle of chemotherapy between the time of stem cell collection and transplant will be excluded from study.
结局指标
主要结局
Scores of the Self-Administered Gerocognitive Exam (SAGE)
时间窗: Before to approximately 100 days after transplant
Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean scores (and standard deviations) for each time points will be presented.
Scores of the Montreal Cognitive Assessment (MoCA)
时间窗: Before to approximately 100 days after transplant
Will be assessed by Montreal Cognitive Assessment (MoCA). The mean scores (and standard deviations) for each time points will be presented.
Changes in scores of the PROMIS Cognitive Function, short form 8a
时间窗: Before to approximately 100 days after transplant
Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function, short form 8a. The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred.
Changes in scores of the Self-Administered Gerocognitive Exam (SAGE)
时间窗: Before to approximately 100 days after transplant
Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred.
Scores of the PROMIS Cognitive Function, short form 8a
时间窗: Before to approximately 100 days after transplant
Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function, short form 8a. The mean scores (and standard deviations) for each time points will be presented.
Changes in scores of the Montreal Cognitive Assessment (MoCA)
时间窗: Before to approximately 100 days after transplant
Will be assessed by Montreal Cognitive Assessment (MoCA). The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred.
次要结局
- Agreement between cognitive test (SAGE and MoCA)(Up to approximately 100 days after transplant)
- Patients' preference between self-assessment tools Questionnaire(Up to 1 year)
- Agreement between cognitive test (PROMIS 8a and SAGE)(Up to approximately 100 days after transplant)
- Agreement between cognitive test (PROMIS 8a and MoCA)(Up to approximately 100 days after transplant)