Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers at Risk for Unplanned ED Visits and Hospitalizations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in overall score of EQ-5D
研究概览
简要总结
This is a randomized trial of patients with gastrointestinal (GI) cancers treated at University of California, San Francisco (UCSF) who are starting a new line of systemic therapy to evaluate the feasibility of electronic patient reported outcome (ePRO) platform.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of the ePRO platform by describing the proportion of participants who engage with the ePRO tool via virtual care chat at least once after enrollment.
II. To investigate the potential differences in health-related quality of life (HRQoL) by comparing the change in overall score of EuroQol five-dimensional Questionnaire (EQ-5D) index.
SECONDARY OBJECTIVES:
I. To evaluate the degree of engagement with virtual care chat as defined by the proportion of chat modules completed.
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
- 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
- •Age 18 years and older
- •Diagnosis of gastrointestinal cancers: esophageal, gastric, hepatocellular carcinoma, cholangiocarcinoma, pancreatic, neuroendocrine, small intestine, colorectal and anal cancers.
- •Patients can have early stage or advanced cancer and will be starting treatment with new, standard of care infusion therapy regimen at UCSF.
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •No limit on prior lines of therapy.
- •Access to smartphone, tablet, or computer with capability to use symptom tracking web site (must have mobile phone number or email address).
- •Willing and able to provide written, signed informed consent in English.
- •Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Patients who have already started therapy prior to study enrollment.
- •Patients who are receiving their treatment outside of UCSF.
- •Participation in another clinical trial (therapeutic or non-therapeutic).
- •Patients who are on therapy with oral oncolytics or combination therapy of oral oncolytics and infusional agents.
- •Patients who are non-English speakers.
结局指标
主要结局
Change in overall score of EQ-5D
时间窗: 6 months
The EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension. Change in overall score of EQ-5D index between the intervention and usual of care arms between baseline and 6 months will be reported
Proportion of patients who engaged with the ePRO tool
时间窗: Up to 6 months
The point estimation of proportion of patients who engaged with the ePRO tool via virtual care chat at least once after enrollment and its 95% binomial confidence interval (CI) will be obtained.
次要结局
- Number of phone calls and secure messages(Up to 6 months)
- Proportion of chat modules completed(Up to 6 months)
- Number of patient-reported symptoms(Up to 6 months)
- Number of patient-reported symptoms that were severe and were escalated(Up to 6 months)
- Proportion of chats in which PRO-CTCAE was offered were completed.(Up to 6 months)
- Change in EQ-5D scores over time(Up to 6 months)
- Mean change in pain score over time.(Up to 6 months)
- Predictive value of ED Visit and/or hospital admission(Up to 6 months)