Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer

Queen Margaret University

Status: Not yet enrolling

Conditions: Oesophageal Cancer; Gastric Cancer; mHealth Application; Prehabilitation

Treatments: Device: Asensei app

Study type: Interventional

Funder types: Other

Identifiers

NCT06046846

321301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Asensei app intervention group

Experimental group

Description:

Participants randomised to the intervention group will be introduced to the mHealth prehabilitation programme delivered via a mobile app. Within this intervention group, participants will have access to a mHealth prehabilitation programme delivered and monitored via an app which will consist of a multimodal prehabilitation programme consisting of nutritional guidelines, improving well being and physical functioning prior to surgery.

Treatment:

Device: Asensei app

Standard Pre-Operative Care group

No Intervention group

Description:

The control group will receive standard pre-operative care within NHS Lothian for patients undergoing surgery for oesophago-gastric cancer which includes the enhanced recovery after surgery pathway. This pathway includes a pre-assessment, verbal advice only on prehabilitation interventions surrounding nutrition, well being and physical activity as well as a follow up post treatment.