Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer

NCT06046846 | Unknown DMC

• 1 other identifier: 321301
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oesophageal Cancer; Gastric Cancer; Prehabilitation; mHealth Application

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  Throughout the 6 weeks prior to surgery

• 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.

  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.

  Throughout the 6 weeks prior to surgery

• 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.

  Compliance will be measured by assessing the extent to which participants adhere to the recommended prehabilitation protocols as well as the study guidelines.

  Throughout the 6 weeks prior to surgery

• 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).

  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.

  The single point of assessment will be 30 days post surgery.

• To investigate the usability in terms of user satisfaction of the asensei app to deliver a mHealth prehabilitation programme.

  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.

  The single point of assessment will be 30 days post surgery.

Secondary Outcomes (10)

• 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 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 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 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 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

Other Outcomes (1)

• Semi structured interviews

  30 days post surgery

Study Arms (2)

Asensei app intervention group

EXPERIMENTAL

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.

Device: Asensei app

Standard Pre-Operative Care group

NO INTERVENTION

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.

Interventions

Asensei app DEVICE

The study will compare the delivery of a prehabilitation programme via a mHealth application against standard preoperative care for patients undergoing surgery for oesophago-gastric cancer

Asensei app intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of oesophago-gastric cancer awaiting surgery,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Margaret University: lead
• Royal Infirmary of Edinburgh: collaborator

Related Publications (2)

• 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.

  PMID: 25760773 BACKGROUND

• 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.

  PMID: 18338319 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Alison Kelly, MRes

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

• Dr Gillian Baer, PhD

  Queen Margaret University

  STUDY DIRECTOR

Central Study Contacts

Alison Kelly, MRes

CONTACT

01314740000; akelly@qmu.ac.uk

Dr Lisa Salisbury, PhD

CONTACT

01314740000; lsalisbury@qmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single centred feasibility randomised controlled trial (RCT)

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: September 21, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available as part of a publication which is expected to be 31/12/2025 at the latest.
• Access Criteria: The access criteria in which the Individual Participant Data (IPD) and any additional supporting information will be shared will become available after publication when summary data are published and otherwise made available. The journal with whom this will be made available is currently undecided.