Clinical trial NCT06046846: Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer
Official title: An Investigation of the Feasibility and Impact of a mHealth Prehabilitation Programme for Patients With Oesophago-gastric Cancer: The mPOC Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oesophageal Cancer
Gastric Cancer
Prehabilitation
mHealth Application
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: Royal Infirmary of Edinburgh
First posted: 2023-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centred feasibility randomised controlled trial (RCT)
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Participants will need to fulfil the following eligibility criteria:

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: Throughout the 6 weeks prior to surgery
measure: 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.
timeFrame: Throughout the 6 weeks prior to surgery
measure: 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.
timeFrame: Throughout the 6 weeks prior to surgery
measure: 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).
timeFrame: The single point of assessment will be 30 days post surgery.
measure: To investigate the usability in terms of user satisfaction of the asensei app to deliver a mHealth prehabilitation programme.
timeFrame: The single point of assessment will be 30 days post surgery.
Secondary outcomes:
measure: To investigate the incidence of treatment-emergent adverse events of using the mHealth prehabilitation programme delivered via the asensei app.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
measure: 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.
timeFrame: From 6 weeks prior to surgery to 30 days post surgery
Other outcomes:
measure: Semi structured interviews
timeFrame: 30 days post surgery
Locations:
Study officials:
affiliation: Queen Margaret University
name: Alison Kelly, MRes
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Margaret University
name: Dr Gillian Baer, PhD
role: STUDY_DIRECTOR
References:
citation: Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.
citation: Crans GG, Shuster JJ. How conservative is Fisher's exact test? A quantitative evaluation of the two-sample comparative binomial trial. Stat Med. 2008 Aug 15;27(18):3598-611. doi: 10.1002/sim.3221.