逐步研究计划，以促进缓解癌症相关疲劳的巧妙在线支持解决方案（STEPPING-STONE） (STEPPING-STONe)
Decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of CRF in cancer patients while also gathering data on the implementation strategy.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ines VAZ-LUIS, MD
- 电话号码：+33 (0)1 42 11 48 27
- 邮箱：ines-maria.vaz-duarte-luis@gustaveroussy.fr
研究联系人备份
- 姓名：Maria Alice FRAZOI, MD
- 电话号码：+33 (0)1 42 11 48 27
- 邮箱：mariaalice.borinelli-franzoi@gustaveroussy.fr
学习地点
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-
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Villejuif、法国、94805
- 招聘中
- Gustave Roussy
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接触：
- Ines VAZ-LUIS, MD
- 电话号码：+33 (0)1 42 11 48 27
- 邮箱：ines-maria.vaz-duarte-luis@gustaveroussy.fr
-
接触：
- Maria Alice FRAZOI, MD
- 电话号码：+33 (0)1 42 11 48 27
- 邮箱：mariaalice.borinelli-franzoi@gustaveroussy.fr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 years and older.
- Having a clinical diagnosis of cancer including patients on active treatment or cancer survivors.
- Self-reporting moderate to severe CRF for at least one week (worst level of fatigue ≥ 4 on a 10-point numerical rating scale, retained in international guidelines as an optimal cutoff for identifying clinically significant CRF).
- Being able to read and understand French.
- Having access to a smartphone.
- Patients must be affiliated to a social security system or beneficiary of the same.
Exclusion Criteria:
- Suffering from current psychiatric disorder or cognitive disorder that would interfere with the ability to consent or participate.
- Currently engaging in cognitive-behavioral therapy.
- Currently engaging in another non-drug (behavioral) clinical trial.
- Suffering from physical related reversible and treatable causes of fatigue (anemia, electrolytes unbalance, infections, renal dysfunction, active metastases causing fatigue, hormonal unbalances (hypothyroidism, adrenal insufficiency, etc.) - according to physician's judgement at the moment of inclusion.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：Educational material aid tool
Educational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions. |
Patients will have access to educational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions. This version is currently public available in France and Belgium at www.resilience.care and is considered the control group (education only). |
|
实验性的：Educational material plus self-management program - self-administered version
Mobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach. |
Patients will have access to the same mobile app (Resilience ©) with its educational content will be powered with a self-guided fatigue self-management program based on a cognitive behavioral therapy approach. |
|
实验性的：Educational material plus self-management program - guided version with mental health professional
Mobile app (Resilience ©) with its educational content and the self-management program of arm 2 plus weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program. |
Patients will have access to the same mobile app (Resilience ©) with its educational content and the self-management program of arm 2 and weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient.
大体时间：3 months and 6 months after the end of the program.
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Compare the effectiveness of standard of care (provided by the patient's cancer center and their treating oncologist) plus three different types of digital aid modalities for the patient (1: educational material; 2: educational material plus self-management program based on a cognitive behavioural therapy strategy - self-administered; 3: educational material plus self-management program based on a cognitive behavioural therapy strategy - guided by a psychologist) in reducing the perceived burden of CRF (cancer-related fatigue), measured as a clinically meaningful change (≥ 6 points) in fatigue scores in the fatigue subscale of the EORTC QLQ C30 questionnaire from baseline to short-term assessments. |
3 months and 6 months after the end of the program.
|
合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.