An Investigation of the Feasibility and Impact of a mHealth Prehabilitation Programme for Patients With Oesophago-gastric Cancer: The mPOC Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- To explore the recruitment of taking part in a mHealth prehabilitation programme delivered via the asensei app for 6-weeks prior to oesophago-gastric surgery.
研究概览
简要总结
The overall aim of this study is to assess the feasibility of a mHealth prehabilitation programme delivered via a mobile app for people with oesophago-gastric cancer by evaluating its user satisfaction and acceptance. The research question asks what is the feasibility of a mHealth prehabilitation programme delivered via a mobile app for patients with oesophago-gastric cancer?
The primary aim of this single centred feasibility randomised controlled trial (RCT) is to explore the recruitment, adherence, and compliance of taking part in a mHealth prehabilitation programme delivered for 6 weeks via a mobile app prior to oesophago-gastric surgery. This study will develop a prehabilitation programme to investigate the feasibility and impact of delivering prehabilitation via a mobile app to patients with a diagnosis of oesophago-gastric cancer before surgery.
详细描述
The study will test a six-week mHealth prehabilitation programme delivered via a modified mobile application called the asensei app. Asensei is a commercial company who have already successfully developed a digital platform known as the asensei app that delivers tailored training with individualised programmes and automated responsive feedback for the fitness industry via mobile applications. In summary, participants recruited to the study will require three visits to the hospital for measures to be taken. Outcome measurements will be taken at baseline (T0), prior to surgery (T1) and 30 days post surgery (T2). Outcome measures relating to feasibility, physical and nutritional functioning as well as quality of life will be collected at the above specified three time points (T0,1,2). There will also be weekly phone calls and one to one discussion after the six weeks of prehabilitation to explore how useful people have found the app and how easy and engaging it was to navigate. This study will gain valuable insight into the role mHealth applications could offer in preventing functional decline, improving quality of life and preventing secondary complications in patients with a diagnosis of cancer prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Diagnosis of oesophago-gastric cancer awaiting surgery,
- •18 years of age or over,
- •Medically stable to participate in a prehabilitation programme with exercise intervention, English speaking,
- •Access to an iPhone
- •Able to provide informed consent.
排除标准
- •Medically unstable,
- •Diagnosis of metastatic cancer,
- •Contraindications for physical activity,
- •Presence of a pacemaker or other internal medical device,
- •Uncontrolled blood pressure and or heart arrhythmias.
结局指标
主要结局
To explore the recruitment of taking part in a mHealth prehabilitation programme delivered via the asensei app for 6-weeks prior to oesophago-gastric surgery.
时间窗: Throughout the 6 weeks prior to surgery
Recruitment will be measured by analysing the proportion of individuals who take up the offer of a mHealth prehabilitation programme delivered via the asensei app prior to surgical intervention.
To investigate the fidelity in terms of user engagement of the asensei app to deliver a mHealth prehabilitation programme using the modified mobile application rating scale (mMARS).
时间窗: The single point of assessment will be 30 days post surgery.
Fidelity of the asensei app use will be measured using the modified mobile application rating scale (mMARS). This scale is a well-established framework for classifying and assessing the objective and subjective quality of apps. The scale assesses app quality which is rated on a 5-point scale from "1.Inadequate" to "5.Excellent". The modified mobile application rating scale typically ranges from 1 to 5, with 1 being the lowest rating and 5 being the highest. Higher scores generally indicate better user satisfaction and positive experiences with the mobile application. It suggests that users find the app to be more useful, user-friendly and enjoyable. Lower scores typically suggest dissatisfaction or negative experiences with the mobile application where users may find the app less useful, difficult to use or unenjoyable. Lower scores could also indicate issues with functionality, design or overall user experience.
To explore the adherence of taking part in a mHealth prehabilitation programme delivered via the asensei app for 6-weeks prior to oesophago-gastric surgery.
时间窗: Throughout the 6 weeks prior to surgery
Adherence with the mHealth prehabilitation will be calculated by analysing the percentage of participants who consistently engage with the asensei app and complete the prescribed prehabilitation programme.
To explore the compliance of taking part in a mHealth prehabilitation programme delivered via the asensei app for 6-weeks prior to oesophago-gastric surgery.
时间窗: Throughout the 6 weeks prior to surgery
Compliance will be measured by assessing the extent to which participants adhere to the recommended prehabilitation protocols as well as the study guidelines.
To investigate the usability in terms of user satisfaction of the asensei app to deliver a mHealth prehabilitation programme.
时间窗: The single point of assessment will be 30 days post surgery.
Usability of the asensei app in terms of user satisfaction will be measured through semi structured interviews to collect participant feedback regarding the applications usability, perceived usefulness, and satisfaction. Higher and lower subjective ratings collated during the interview could represent different aspects of the app's performance and user experience. For example, a higher rating within interviews among participants may typically represent greater satisfaction with the mobile app with an increase likelihood to find the app user friendly, useful, and enjoyable to use. On the other hand, lower subjective feedback may typically signify dissatisfaction with the app.
次要结局
- To investigate the incidence of treatment-emergent adverse events of using the mHealth prehabilitation programme delivered via the asensei app.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data on aerobic capacity and assess for change using the 6 minute walk test (6MWT) in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data on a participants lower extremity strength and frailty and assess for change using the five times sit to stand test (5XSST) in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data and assess for change on a participants anthropometry such as body composition in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data on physical activity and assess for change using the Godin Leisure time Exercise questionnaire in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data on a participants mobility and balance and assess for change using the timed up and go test (TUAG) in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data and assess for change on a participants handgrip strength using the hand dynamometer in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data and assess for change on a participants risk of malnutrition by using PG-SGA questionnaire in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data and assess for change on a participants wellbeing by using the patient health questionnaire (PHQ-9) in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
- To collect preliminary data and assess for change on a participants quality of life by using the EORTC QLQ-OG25 questionnaire in order to inform the sample size for a fully powered RCT as part of the feasibility study.(From 6 weeks prior to surgery to 30 days post surgery)
研究者
Alison Kelly
Principal Investigator
Queen Margaret University