Oesophageal CancerNCT06046846
Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer
A study testing Asensei app in people with Oesophageal Cancer and Gastric Cancer, run by Queen Margaret University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer, Prehabilitation
- What is being tested?
- Asensei app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: An Investigation of the Feasibility and Impact of a mHealth Prehabilitation Programme for Patients With Oesophago-gastric Cancer: The mPOC Study
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.
Read the 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.
- Being tested
- Asensei app
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asensei appDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Any adverse effects of using the asensei app will be measured through participant monitoring via agreed weekly phone calls throughout the prehabilitation programme. These phone calls will collect data on any related treatment-emergent adverse events. Any reported events or concerns will be analysed systematically, and any events reported will be categorized according to severity, frequency, and the nature of the adverse effects.
Measured: 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.
Preliminary data on physical activity will subjectively measure physical activity using the self-administered Godin Leisure Time Exercise Questionnaire which is a validated self-reported physical activity measurement used in cancer care. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The minimum and maximum values within the questionnaire used ranges from (0-119) where higher scores indicate higher level of leisure time exercise participation.
Measured: 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.
The 6-minute walk test (6MWT) will assess the distance walked over 6 minutes as a sub-maximal test of aerobic capacity. This outcome measure will be used to determine changes in physical function levels and cardiorespiratory fitness. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The minimum score is zero indicating that the participant was unable to walk any distance within the six minute time frame and the highest score is the distance walked by the participant in six minutes.
Measured: 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.
The timed up and go test (TUAG) will assess a person's mobility and balance using the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The lower the time score represents the shortest time taken to complete the task, indicating better mobility and functional ability. The higher the time score represents the longest time taken to complete the task suggesting potential mobility issues or functional limitations.
Measured: 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.
The Five times sit to stand test (5XSST) will assess lower extremity strength and frailty in patients with cancer. It is a simple test that evaluates the time taken to complete five repetitions of standing up from a seated position and sitting back down again. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The lowest score is the shortest time taken to complete the task, indicating better lower body strength and mobility. The highest score is the longest time taken to complete the task, suggesting potential difficulties in lower body strength and functional mobility.
Measured: 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.
Anthropometry will be assessed as height, weight, and body composition. Body composition will be assessed and calculated using Body Mass Index in the standard manner as height and weight. These multiple measurements will be aggregated to arrive at one reported value (e.g., weight and height will be combined to report BMI in kg/m) This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2).
Measured: 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.
The handgrip test will be assessed and measured using a hand dynamometer to assess for grip strength. Handgrip strength can be used in cancer patients to evaluate nutritional risk and the need for nutritional intervention. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). It measures the maximum force a person can generate while squeezing a handgrip dynamometer. The score is typically measured in kilograms and indicates the strength of the participants hand muscles. The lowest score is the weakest grip strength measurement achieved by the participant and the highest score is the strongest grip strength measurement obtained during the test.
Measured: 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.
The Patient Generated Subjective Global Assessment questionnaire (PG-SGA) will be used as an assessment tool to identify those most at risk of malnutrition. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). It does not have a specific numerical score range like some other tests. Instead it involves a series of questions and assessments that are used to evaluate a participants weight changes, dietary intake, symptoms and functional capacity. The results are typically categorised into different levels of malnutrition of nutritional risk, ranging from well nourished to severely malnourished.
Measured: 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.
The patient health questionnaire (PHQ-9) will be used as an assessment tool to identify those participants in need of further support out with the universal programme provided by the asensei app. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The PHQ-9 is a self assessment tool used to screen and assess the severity of depression. It consists of nine questions that measure the frequency of various depressive symptoms over the past two weeks. The PHQ-9 scores range from 0-27, with higher scores indicating greater severity of depressive symptoms and the lowest score is 0 indicating the absence of depressive symptoms.
Measured: 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.
The EORTC QLQ-OG25 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- Oesophagogastric Module 25) is a validated screening tool used in the quality-of-life metric pilots for patients with oesophageal-gastric cancer to be assessed for change at three different time points: baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The scoring for the EORTC QLQ-OG25 questionnaire is not a simple numerical range. It involves transforming raw scores into a scale of 0 to 100, where higher scores represent better functioning or higher levels of symptomatology, depending on the question. For example, higher scores on functional scales indicate better function and well-being, while higher scores on symptom scales indicate more severe symptoms. The scores are then interpreted in relation to the patient's condition and the context of their cancer diagnosis and treatment.
Measured: From 6 weeks prior to surgery to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centred feasibility randomised controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Infirmary of Edinburgh
- Responsible party
- Principal investigator, Alison Kelly, Queen Margaret University
- Investigators
- Alison Kelly, MRes, Principal investigator, Queen Margaret UniversityDr Gillian Baer, PhD, Study director, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046846
- Sponsor's protocol ID
- 321301
- Status last verified
- Sep 2023
- First submitted
- 14 Jul 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Overall study outcomes will be shared
Publications
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.
PubMed 25760773Crans 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.
PubMed 18338319
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Feasibility and Impact of a mHealth Prehabilitation Programme for Patients With Oesophago-gastric Cancer: The mPOC Study
- ClinicalTrials.gov ID
- NCT06046846
- Acronym / sponsor ID
- 321301
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Royal Infirmary of Edinburgh
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centred feasibility randomised controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Asensei app intervention group | Experimental | Device: Asensei appParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asensei appThe 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 | Device | Asensei app intervention group |
Primary outcome
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.
Time frame: 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 explore the adherence of taking part in a mHealth prehabilitation programme delivered via the asensei app for 6-weeks prior to oesophago-gastric surgery.
Time frame: 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.
Time frame: 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 fidelity in terms of user engagement of the asensei app to deliver a mHealth prehabilitation programme using the modified mobile application rating scale (mMARS).
Time frame: 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 investigate the usability in terms of user satisfaction of the asensei app to deliver a mHealth prehabilitation programme.
Time frame: 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.
10 secondary outcomes
To investigate the incidence of treatment-emergent adverse events of using the mHealth prehabilitation programme delivered via the asensei app.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From 6 weeks prior to surgery to 30 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 25760773Stoyanov 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.
- Background: PubMed 18338319Crans 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.
- Individual participant dataSharing planned: Yes. Overall study outcomes will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Kelly, MRes principal investigator
Queen Margaret University
Dr Gillian Baer, PhD study director
Queen Margaret University
Questions about this trial
What is this clinical trial studying?
A study testing Asensei app in people with Oesophageal Cancer and Gastric Cancer, run by Queen Margaret University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alison Kelly, MRes (01314740000, akelly@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Throughout the 6 weeks prior to surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046846, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.