ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility - Recruitment
研究概览
简要总结
Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer
详细描述
A single arm feasibility study will be conducted to examine the feasibility of delivering the 12-week ReStOre programme (aerobic and resistance physiotherapy led-exercise, 1:1 dietary counselling and group education sessions) via telehealth to a cohort of upper gastrointestinal cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be ≥ three months post oesophagectomy, total gastrectomy
- •± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
- •adjuvant therapy must be completed
- •access to home broadband
排除标准
- •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%.
结局指标
主要结局
Feasibility - Recruitment
时间窗: Through study completion approx 1 year
Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
Feasibility - adherence
时间窗: From baseline (T0) to immediately after the program intervention (T1)
Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.
Feasibility - acceptability of the intervention (1)
时间窗: Immediately after the program intervention (T1)
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.
Feasibility - acceptability of the intervention (2)
时间窗: 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).
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
次要结局
- Change in Cardiorespiratory Fitness from Baseline(Baseline (T0), Immediately after the program intervention (T1))
- Physical Performance(Baseline (T0), Immediately after the program intervention (T1))
- Hand Grip Strength(Baseline (T0), Immediately after the program intervention (T1))
- Physical Activity(Baseline (T0), Immediately after the program intervention (T1))
- Weight(Baseline (T0), Immediately after the program intervention (T1))
- Height(Baseline (T0), Immediately after the program intervention (T1))
- Body Mass Index(Baseline (T0), Immediately after the program intervention (T1))
- Circumferential Measurements(Baseline (T0), Immediately after the program intervention (T1))
- 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)(Baseline (T0), Immediately after the program intervention (T1))
- 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.(Baseline (T0), Immediately after the program intervention (T1))
- Fatigue(Baseline (T0), Immediately after the program intervention (T1))
- Bio-sample Collection(Baseline (T0), Immediately after the program intervention (T1))
研究者
Prof Juliette Hussey
Professor of Physiotherapy
University of Dublin, Trinity College