Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Patient Activation
研究概览
简要总结
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The main question it aims to answer are:
• Does All4Cure effect patient activation as assessed by the PAM-13 survey?
Participants will be asked to:
- fill out quarterly PAM-13 surveys through the All4Cure website to assess patient activation.
- fill out monthly Patient Reported Outcome (PRO) surveys through the All4Cure website.
- fill out a baseline and exit All4Cure surveys through the All4Cure website to assess patient perceptions of All4Cure at the beginning and the end of the study.
详细描述
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma.
This study uses surveys to assess attitudes and perceptions of patients with myeloma at baseline and following their enrollment into All4Cure. The PAM-13 surveys will be administered at baseline and at 3-month intervals for a total of 5 surveys over 12 months. Patient attitudes and perceptions about the All4Cure platform will be assessed at baseline and at 12 months. Physicians caring for patients enrolled in this study will be surveyed twice -- at baseline and when all their patients have completed the study. Additionally, all patients will receive monthly surveys to assess symptoms associated with myeloma and its treatment using 36 survey items obtained from Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
The study has the following objectives:
Primary objective To evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The primary endpoint is the effect of All4Cure on patient activation, as assessed by the PAM-13 survey (change in results from baseline survey to the last completed survey).
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •have a diagnosis of multiple myeloma.
- •are aged 18 years and older.
- •can read and e-consent to participate in the study.
- •can speak English.
- •can complete surveys at pre-specified intervals.
- •have access to a device that would allow for the completion of surveys (including at home, at work, at the oncologist's office or elsewhere).
- •are cared for by a physician who is enrolled in All4Cure.
排除标准
- •1. Patients will be excluded who are unable to engage with All4Cure or are already participants in All4Cure.
结局指标
主要结局
Patient Activation
时间窗: 24 months
Patient activation emphasizes patients' willingness and ability to take independent actions to manage their health and care. A widely used definition equates patient activation with understanding one's role in the care process and having the knowledge, skill, and confidence to manage one's health and health care. A growing body of evidence shows that patients who are more activated have better health outcomes and care experiences. This will be assessed through the PAM-13 survey which has a scale of 1-4, with 4 being the highest level of patient activation and associated with the best patient outcomes and 1 being the lowest level of patient activation.
次要结局
- Evaluate associations between Patient Activation and symptom burden(24 months)
- Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma(24 months)