ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer (ReStOre@Home)
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Leinster
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Dublin、Leinster、爱尔兰
- Trinity College Dublin
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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:
- be ≥ three months post oesophagectomy, total gastrectomy
- ± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
- adjuvant therapy must be completed
- access to home broadband
Exclusion Criteria:
- Ongoing serious post-operative morbidity
- Evidence of active or recurrent disease.
In addition those with any serious co-morbidity that would impact on exercise participation will be excluded including those with;
- Uncontrolled hypertension (resting systolic blood pressure >180mmHg and/or diastolic >100mmHg)
- Recent serious cardiovascular events (within 12 months) including, but not limited to cerebrovascular accident, and myocardial infarction
- Unstable cardiac, renal, lung, liver or other severe chronic disease
- Uncontrolled atrial fibrillation
- Left ventricular function <50%.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 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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实验性的:Intervention Arm
Single arm trial, all participants will receive the intervention
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12 week programme of; 1) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions |
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 |
|---|---|---|
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Feasibility - Recruitment
大体时间:Through study completion approx 1 year
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Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
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Through study completion approx 1 year
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Feasibility - adherence
大体时间:From baseline (T0) to immediately after the program intervention (T1)
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Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.
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From baseline (T0) to immediately after the program intervention (T1)
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Feasibility - acceptability of the intervention (1)
大体时间:Immediately after the program intervention (T1)
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Feasibility will also be determined by the acceptability of the programme. Acceptability of the telehealth programme will be assessed by the Telehealth Usability Questionnaire (TUQ). The Telehealth Usability scale is a 5 point likert scale where 1 = completely disagree, and 5 =fully agree, Higher ratings indicate better usability. |
Immediately after the program intervention (T1)
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Feasibility - acceptability of the intervention (2)
大体时间:Duration of the trial i.e. From enrolment of the first participant until completion of the final participants post-intervention assessment (Time period of up to 12 months).
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Acceptability of the intervention will be further determined by a qualitative approach.Interviews will be carried out with participants post-intervention to gain their perspectives of the impact of the program on physical and mental well-being and the suitability of the programme to delivery via telehealth
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Duration of the trial i.e. From enrolment of the first participant until completion of the final participants post-intervention assessment (Time period of up to 12 months).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Cardiorespiratory Fitness from Baseline
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
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Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance will be measured with the Short Physical Performance Battery
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Baseline (T0), Immediately after the program intervention (T1)
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Hand Grip Strength
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Hand Grip strength will be measured with hand held dynamometry
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Baseline (T0), Immediately after the program intervention (T1)
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Physical Activity
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Physical activity will be measured using the Godin Shepherd Leisure-Time Exercise Questionnaire.
A score of 24 indicates the individual is active, 14-23 indicates moderately active, and less than 14 indicates sedentary/ insufficiently active.
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Baseline (T0), Immediately after the program intervention (T1)
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Weight
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Weight will be recorded by standard measures and reported in kilograms (kg).
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Baseline (T0), Immediately after the program intervention (T1)
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Height
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Height will be recorded by standard measures and reported in meters (m)
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Baseline (T0), Immediately after the program intervention (T1)
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Body Mass Index
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).
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Baseline (T0), Immediately after the program intervention (T1)
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Circumferential Measurements
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)
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Baseline (T0), Immediately after the program intervention (T1)
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Health Related Quality of Life measured by the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden. |
Baseline (T0), Immediately after the program intervention (T1)
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Oesophago-gastric cancer specific Health Related Quality of Life will measured by the European Organisation for the Research and Treatment of Cancer Oesophago-gastric Cancer Subscale the EORTC-QLQ-OG25.
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Oesophagogastric cancer specific quality of life will be determined by the EORTC-QLQ-OG25 subscale. Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden. |
Baseline (T0), Immediately after the program intervention (T1)
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Fatigue
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
It is scored from 0-20.
A cut off score of >or =13 indicates severe fatigue.
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Baseline (T0), Immediately after the program intervention (T1)
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Bio-sample Collection
大体时间:Baseline (T0), Immediately after the program intervention (T1)
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Serum, Plasma and Whole Blood samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.
These samples will be stored in the biobank for future to be determined studies.
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Baseline (T0), Immediately after the program intervention (T1)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
与本研究相关的术语
其他研究编号
- DIFA-2018-009 - ReStOre@Home
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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