Phase II SBIR - CAMPFIRE: An Electronic Platform for Cognitive Assessment in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Completion
研究概览
简要总结
The purpose of this study is to test the feasibility (acceptability and usability) and usefulness of the CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system, a patient-facing portal able to collect and produce reports for clinicians on Patient Reported Outcome Measurement Information System (PROMIS-Cognitive Function/Anxiety/Depression) outcomes via MyChart and NIH Toolbox, an inperson brief objective cognitive function battery. This study will aim to determine the value of the CAMPFIRE system for patients and providers as a tool for monitoring cognitive symptoms throughout the course of chemotherapy
详细描述
CAMPFIRE is a health informatics platform and research tool that seeks to improve clinical research and treatment of cognitive sequelae of cancer and chemotherapy. CAMPFIRE provides curated digital assessments with content specifically for cognitive and psychosocial function assessment, and automates and integrates the data collection, analysis and visualization process into clinical workflows. CAMPFIRE is designed to both improve the availability of data on cognitive impairments among cancer patients, and to improve the integration of the produced data into the care process to efficiently improve outcomes. Key to the overall success of CAMPFIRE is the inclusion of well-validated measures to assess function in cognitive domains often affected in cancer patients, including attention, executive function, working memory, verbal and visuospatial abilities and verbal fluency.
The subjects will be asked to complete a cognitive assessment survey through a link to CAMPFIRE PROMIS in their MyChart account prior to beginning chemotherapy, between 6 - 9 weeks and prior to a post-chemotherapy follow up clinic visit. Subjects will also be asked to complete a brief cognitive assessment (NIH Toolbox) on an iPad in the JPWCI prior to their scheduled clinic visits at the same three study assessment time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have diagnosis of cancer
- •Must be scheduled to receive any standard course of curative intent cytotoxic chemotherapy
- •Must have a computer, a general knowledge of how to use a computer and access to the internet
- •Must be able to speak and read English
- •Must be 21 years or older
- •Must provide informed consent
排除标准
- •Must not be currently hospitalized or have been hospitalized for any psychiatric illness within the last year
- •Must not be diagnosed with neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
- •Must not have any CNS disease (e.g., movement disorder, multiple sclerosis)
结局指标
主要结局
Completion
时间窗: Post-Chemotherapy (16-18 weeks)
To determine the proportion of patients who complete the full-scope CAMPFIRE NIH PROMIS and NIH Toolbox battery throughout treatment (i.e., pre-chemotherapy time-point, 6-9 week time-point, post-chemotherapy time-point) Among the enrolled patients we will calculate proportions of patients who complete the full CAMPFIRE workflow at multiple time points: (1) at pre-chemotherapy; (2) at post-chemotherapy; and (3) at any time point in between. Similarly, proportions of completers will be calculated for each collection of measures for CAMPFIRE (NIH PROMIS and NIH Toolbox). The differences in completion of tests by age and gender will be compared. For individual tests, we will determine the proportion of patients completing the test and use descriptive statistics to summarize data. Descriptive statistics will be used to characterize the cohort of enrolled patients.
次要结局
- Provider Action(Post-Chemotherapy (16-18 weeks))
- Changes in Cognition via NIH Toolbox Assessment(Post-Chemotherapy (16-18 weeks))
- Changes in Cognition via PROMIS Surveys(Post-Chemotherapy (16-18 weeks))
- Participant Feedback(Post-Study (18-20 weeks))
研究者
Michelle Janelsins, PhD, MPH
Associate Professor
University of Rochester