Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Health outcomes for cancer recurrence using PSA
研究概览
简要总结
This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to enhance patient education may improve patient understanding and result in higher patient satisfaction with treatment decisions amongst men with PC.
详细描述
PRIMARY OBJECTIVES:
I. To develop an adaptive virtual consultation tool for PC (AVCT):
Ia. To incorporate and integrate the inputs from a diverse group of patients (including minorities), patient advocates, nursing, physicians and education experts in the design process for the adaptive consultation tool; Ib. Employ user centered iterative design approach to develop an adaptive learning tool on mobile devices that is tailored to individuals based on symptoms, health literacy, learning style, and disease specific characteristics.
II. To assess the feasibility, acceptability and usability of AVCT:
IIa. To validate the design approach and customization rules at the completion of the participatory design process using a convenience sample of subjects through assessment of system interaction logs and qualitative feedback from users on cognition, ease-of-use, usability and customization efficacy; IIb. To utilize the feasibility study results in (2a) to refine the interface, information presentation, and adaptive customization approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The participants in this study will be community dwelling, males with prostate cancer (PC) and their healthcare advocate, if applicable
- •Proficiency in English is required
排除标准
- •Mental incompetency to participate in the study and/or no treatment option due to other health reasons
结局指标
主要结局
Health outcomes for cancer recurrence using PSA
时间窗: 12-months post treatment decision
Measured by Prostate specific antigen ( PSA )
Health outcomes for sexual function using SHIM score
时间窗: Baseline
Measured using Sexual Health inventory for men (SHIM) score
Health outcomes for urinary function
时间窗: 12-months post treatment decision
Measured using International Prostate symptom score (IPSS)
Health outcomes for urinary function using IPSS
时间窗: Baseline
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function
时间窗: 12-months post treatment decision
Measured using Sexual Health inventory for men (SHIM) score
Patient satisfaction measured by post utilization surveys
时间窗: 12-month post treatment decision
Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools. Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
次要结局
未报告次要终点
研究者
Mitchell Humphreys
Principal Investigator
Mayo Clinic