Feasibility Study to Evaluate a Digital Tool for Monitoring Patients Who Have Discontinued Treatment for Chronic Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: - once a month, if treatment interruption is ≤ 6 months; - once a quarter, if treatment interruption is > 6 months.
研究概览
简要总结
The objective of this project is to evaluate, over a 12-month period, the feasibility of integrating a digital tool into the follow-up care of patients with chronic myeloid leukemia who have been off treatment for up to 2 years. Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least:
- once a month, if treatment discontinuation was ≤ 6 months;
- once a quarter, if treatment discontinuation was > 6 months. The usage rate will be assessed and compared to a threshold of 60%; if the rate falls below this threshold, feasibility will be considered insufficient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or older
- •Patients with chronic myeloid leukemia who have been off treatment for ≤ 2 years
- •Patients with access to a digital device with internet access
- •Be enrolled in the social security system
- •Have given verbal consent after reviewing the study information sheet
排除标准
- •Patients who cannot read or understand French;
- •Individuals entitled to enhanced protection, namely minors, individuals deprived of their liberty by a judicial or administrative decision, individuals staying in a health or social care facility, adults under legal guardianship, and, finally, patients in emergency situations
研究组 & 干预措施
Intervention arm
Integration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years.
干预措施: Integration of a digital tool (Other)
结局指标
主要结局
Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: - once a month, if treatment interruption is ≤ 6 months; - once a quarter, if treatment interruption is > 6 months.
时间窗: 12 months
To evaluate, over a 12-month period, the feasibility of integrating a digital tool into the care of patients with chronic myeloid leukemia
次要结局
- Changes in the GAD-7 anxiety score (0 to 21) based on the duration of treatment interruption (months) and the frequence(12 months)
- Number of times patients used the device.(12 months)
- The number of days between when the blood test is performed and when the IPA and the patient view the results on the device.(12 months)
- The frequency with which patients contact the study nurse through the system's communication module.(12 months)
- Anxiety scores will be assessed at enrollment, at M3, M6, and M12 using the 7-item Generalized Anxiety Disorder Screening Scale (GAD-7) (scores range from 0 to 21).(12 months)
- Patient satisfaction will be assessed using a questionnaire designed specifically for this population, consisting of 9 items (with a score ranging from 0 to 36) and a numerical scale for overall satisfaction ranging from 0 to 10.(12 months)
- The tool's usability will be evaluated using the 10-item System Usability Scale (SUS) (0 to 100).(12 months)
研究者
Cindy JAFFRY
Principal investigator
Versailles Hospital