LCI-GER-NOS-TAB-001: Pilot Study of a Tablet to Administer the Cancer-Specific Geriatric Assessment (CSGA) in Geriatric Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Survey completion rate
研究概览
简要总结
The Self Geriatric Assessment Measure [SGAM] is based on a standard diagnostic tool used to evaluate geriatric cancer patients in order to determine the appropriateness of cancer directed therapy at LCI. This questionnaire has sections that matches portions of a self-administered geriatric assessment in patients aged 70 or older with malignancy. The prolonged duration of time needed to complete the assessment makes its performance less feasible in standard practice settings.
In previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been provided both via written questionnaire and by personal computer in subjects 70 years of age or older. With improvements in technology, the goal is to evaluate the feasibility of administering the SGAM via an iPad tablet and compare results to both gold standard paper format and prior desktop computer data.
This study proposes the use of an iPad tablet to administer the SGAM may help:
Improve the completion rate of the SGAM assessment Reduction in the time of completion Improvement in the accuracy of reporting
详细描述
Primary Objective
Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the Self Geriatric Assessment Measure (SGAM) in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.
Secondary Objectives
To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.
To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria:
- •At least 70 years of age
- •Histologically or cytologically confirmed malignancy within the past 1 year
- •Ability to read and understand English
- •Willingness to complete either tablet or paper based assessment independently and without assistance from caregiver, if applicable
- •Willingness and ability to understand and sign a written informed consent document
排除标准
- •Subjects must not meet any of the following criteria:
- •Any prior history of whole brain radiation therapy for known brain metastasis
- •Known cerebrovascular event within the last 4 weeks from enrollment
- •Known to be legally blind or has a history of severe hearing loss that could impair ability to complete questionnaire in the opinion of the investigator
研究组 & 干预措施
1
iPad administration of Self Geriatric Assessment Measure (SGAM)
干预措施: Self Geriatric Assessment Measure (SGAM) (Other)
2
Paper survey administration of Self Geriatric Assessment Measure (SGAM)
干预措施: Self Geriatric Assessment Measure (SGAM) (Other)
结局指标
主要结局
Survey completion rate
时间窗: 12 months
Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the SGAM in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.
次要结局
- Total time of interaction with iPad survey(12 months)
- Percentage of recorded responses(12 months)
- Rate of technical issues within iPad group(12 months)
- Rate of survey completion without assistance(12 months)