Testing Two Implementation Strategies in Collecting ePRO Among Multiple Myeloma Patients: ePRO4MM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- The primary endpoint is the number of completed ePRO responses, assessed in the course of 6 months, based on group. This is a numeric endpoint.
研究概览
简要总结
This clinical trial evaluates satisfaction and engagement with a text messaging platform (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM typically receive continuous therapy from the time of diagnosis, which often comes with treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains such as physical and emotional well-being, social functioning, and financial burden. Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can generate information to help facilitate clinical decision making and follow up care. PROs are direct reports from patients about their health status. Compared with paper versions, electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their clinic visit, facilitate direct data collection through the electronic health record, and enable clinicians to track symptoms long-term. The use of ePROs is associated with improved patient health outcomes, including better quality of life, reduced emergency department usage, and prolonged overall survival. The increased use of electronic communication technologies to capture PRO data long-term has been implemented through various methods including web-based, social media, text messages, mobile applications, and electronic portals. Text messaging is an accessible, though under-explored, communication channel for promoting ePRO collection. Information gathered from this study may help researchers understand MM patients' preferences for reporting symptoms via text message compared to a patient portal system.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, considering their demographic information.
II. To evaluate each patient's adherence to the approach of his/her own choice by examining their utilization of the ePRO.
SECONDARY OBJECTIVE:
I. To examine the usability and satisfaction of the two implementation approaches of each patient's choice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Diagnosis of MM
- •Able to use TXT or have Internet access
- •Can read and understand English
- •If patients are undergoing an autologous stem cell transplant, they will be enrolled after their transplant
排除标准
- •< 18 years of age
- •Cognitive impairment documented in the electronic medical record (EMR)
结局指标
主要结局
The primary endpoint is the number of completed ePRO responses, assessed in the course of 6 months, based on group. This is a numeric endpoint.
时间窗: At 6 months
This is a numeric endpoint. For the primary analysis, the number of completed ePRO responses, over the course of 6 months, will be summarized using means and standard deviations, for the two implementation approaches. Multivariable Poisson regression analysis will be performed to explore the relationship between this endpoint and implementation approaches, age, gender, etc., with special consideration of the interaction between race (African American vs. Caucasian) and implementation approaches.
次要结局
- The second endpoint is patients' satisfaction from survey at the end of the intervention.(At 6 months)
