Fit 4 Surgery 2: Using an app to get fit for lung cancer surgery
| ISRCTN | ISRCTN40412033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40412033 |
| IRAS number | 317416 |
| Secondary identifying numbers | CPMS 55877, NIHR134214, IRAS 317416 |
- Submission date
- 25/04/2023
- Registration date
- 04/05/2023
- Last edited
- 01/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Surgery remains the best option for the cure of patients with lung cancer. Around 7000 people in the UK undergo lung surgery each year, but up to 45% of patients developed post-operative complications leading to readmission to hospital and potentially poorer quality of life. National and international cancer, surgery and nutrition guidelines recommend a combination of exercise and nutritional support before and after surgery to help reduce post-operative complications. However it is not clear what is the best way to deliver this. Personalised exercise, nutrition and health information programmes delivered via an App may be a way to provide the right advice and support at the right time for each individual patient.
The F4S-2 trial aims to find out if providing an App that delivers personalised exercise, nutrition and health information, in addition to any support that lung surgery patients would normally receive, improves physical recovery, reduce the chances of developing complications or the impact of them on quality of life, and save cost in the NHS.
Who can participate?
To be eligible for the trial, patients must be: aged 18 or over; with a suspected clinical or pathological diagnosis of primary lung cancer; undergoing elective curative lung resection; able to undergo F4S-2 intervention for minimum 2 weeks prior to surgery; able to complete F4S-2 questionnaires and provide informed consent.
What does the study involve?
We will invite 902 patients from 20 NHS Trusts into the trial. All participants will receive usual care, but half of the group (allocated randomly) will also use the App. We will follow the progress of all participants for 6 months.
The trial has an embedded ‘Study Within A Trial’ that aims to find out reasons behind patients declining to join the trial and provide valuable information for the design of future exercise and nutrition clinical trials.
What are the possible benefits and risks of participating?
Training/rehabilitation programmes delivered via the App may reduce the risk of complications occurring after surgery. Whilst there is no direct benefit to participants in the usual care group, the information gained from this study will help us determine whether the App is any better than what we already provide i.e. usual care.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
May 2022 to December 2027
Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Laura Ocansey, l.ocansey@bham.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-app-help-with-exercise-diet-programme-before-lung-cancer-surgery-fit-4-surgery-2
Contact information
Scientific
University of Birmingham
Institute of Inflammation and Ageing
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0003-1576-230X |
|---|---|
| Phone | +44 121 3713228 |
| b.naidu@bham.ac.uk |
Public
Birmingham Clinical Trials Unit
Applied Health Research
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0009-0007-7139-7008 |
|---|---|
| Phone | +44 121 415 9115 |
| l.ocansey@bham.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 43550 F4S-2 PIS V3.0 18Apr2023.pdf |
| Scientific title | Fit 4 Surgery 2: A randomised controlled trial to investigate an App-based, motivation-theory grounded, personalised, comprehensive, prehabilitation programme in addition to usual care versus usual care alone to enhance recovery of physical function and reduce complications after lung cancer surgery |
| Study acronym | F4S-2 |
| Study hypothesis | The F4S-2 trial aims to find out if providing an App that delivers personalised exercise, nutrition and health information, in addition to any support that lung surgery patients would normally receive, improves physical recovery, reduce the chances of developing complications or the impact of them on quality of life, and save cost in the NHS. |
| Ethics approval(s) | Approved 27/04/2023, East of England – Essex Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 2071048227; Essex.REC@hra.nhs.uk), ref: 23/EE/0079 |
| Condition | Recovery from lung cancer surgery |
| Intervention | TRIAL INTERVENTION Usual Care vs F4S-2 digital platform (App) and Usual care Usual Care: This may be a range of healthcare services that provide all or one of the following: information for the participant (with or without links to further information), formal rehabilitation via physiotherapy, nutritional support via dietitian, and/or routine follow up as per standard of care. THE F4S-2 APP The advice given to the participant is determined by their unique, dynamic, personal health status. That is, as a patient engages with the App, the advice regarding exercise and nutrition adapts. Specifically, the App collects baseline demographic data, comorbidities, symptom burden using simple questions and Visual Analogue Scales, and the outcome measures of Quality of Life, Health and wellbeing scores. This information is used to deliver personalised feedback, support and guidance when using the App. e.g. if diabetic, guidance on avoiding a hypoglycaemic event. This will not constitute trial data, and is part of the data to inform the intervention itself. The digital programme or ‘App’ comprises three prehabilitation interventions. STRUCTURED HOME EXERCISE PROGRAMME: Participants are guided through a series of screens to build their own programme, including a range of strengthening, mobility and cardiovascular exercises. Baseline suggestions on programme level/ intensity are made based on a ‘sit to stand test’ conducted within the App. Once the programme is built, participants are encouraged to exercise daily to achieve 150 minutes of exercise/week as per pulmonary rehabilitation guidelines. Heart rate is recorded using a wearable sensor provided free of charge to the participants. Once each exercise is completed, the participant inputs their perceived intensity using the BORG perceived exertion scales to the App. This data is used to encourage the participant via personalised messages to increase or decrease intensity at the next session to achieve the target intensity of BORG perceived exertion as per rehabilitation guidelines. Regular data uploads allow health care professionals (HCP) to view participants’ progress, whilst the App allows the participant to request support from the health care professional HCP if required. Only these health care professionals are able to view the information within the App. They will be able to see alerts from the participant through the admin page. The App app has safety messages to advise participants to seek medical advice when required (in the same way that usual care patients are directed to contact depending on the situation). Participants are also able to record any other exercise they undertake e.g. swimming, running etc. Whilst the programme is focused on pre-surgery, exercise can also benefit recovery post-surgery, so the participant will be permitted to use the programme after surgery for a period of 6 weeks, but it will be adapted/reset according to participants’ post-surgery ‘sit to stand test’ performance (on postoperative day 1). INDIVIDUALISED NUTRITIONAL CONDITIONING: At the time of enrolment, participants complete a nutritional screening questionnaire (Participant-Generated Subjective Global Assessment (PG-SGA score)) within the App, which tailors nutritional advice and supplementation based on symptoms and nutritional risk. All participants will be encouraged with the aid of a “ready reckoner” to intake a high protein (20g) snack within 90 minutes of exercise to stimulate muscle protein synthesis and a positive protein balance. Participants will record in the App when they have taken a protein snack. Participants deemed ‘Medium risk’ (PG-SGA score 4-9) will be started on a low volume, high calorie, high protein oral nutritional supplement (ONS) containing at least 18g of protein twice a day until surgery. High risk participants (score ≥ 9) will be started on supplements as above and referred to a dietitian for optimisation of supplement prescription. While the recommendations above are aligned with national guidance, sites can adhere to local policies. Whilst the programme is focused on pre-surgery, it is acknowledged that after surgery, calorie and protein requirements are high at a time when intake may be impaired by the after effects of surgery. Therefore, nutritional intervention will continue for 4 weeks post-surgery. Participants will complete the PG-SGA using the App on postoperative day 1, and based on this nutritional advice and supplementation will be tailored as described above. Standard care will be followed regarding the supplementation and monitoring PERSONALISED HEALTH INFORMATION: Displayed within the App as short informational videos with subtitles. Information is responsive, and guided by symptom data and whether the participant is pre- vs. post-surgery, as recorded in the App. For example, if the participant reports feeling breathless, information on how best to manage this is displayed. Information on surgery is prominent to the participant before surgery, whilst recovery and symptom management e.g. pain control are prominent after. Further details of the programme can be found on https://www.Fit4surgery.uk. Motivational processes – In app data collection will include Motivational processes underpinning engagement with the App/behaviour change, autonomous and controlled motivation for engagement in exercise and physical activity and an assessment of autonomy, competence, and connection |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Patient-reported quality of physical function scale recovery (using the EORTC-QLQ-C30) at 30 days after surgery 2. Surgical complications (using the Comprehensive Complication Index (CCI)) at 30 days after surgery |
| Secondary outcome measures | Current secondary outcome measures as of 24/10/2024: 1. Days Alive and at Home Within 30 days (DAH30) 2. Patient-reported quality of life (using the EORTC-QLQ-C30 & LC 29) at Baseline, Day of Surgery, 30 days, 3 and 6 months after surgery 2.1. EORTC-QLQ-C30 Domains: Global Health Status, Physical Functioning, Role Functioning, Emotional Functioning, Cognitive Functioning, Social Functioning 2.2. EORTC-QLQ-LC29 Domains: Coughing, Shortness of Breath, Side Effects of Treatment, Fear of Progression, Surgery related problems 3. Mental health/well-being (using the Hospital Anxiety and Depression at Scale (HADS)) at Baseline, Day of Surgery, 30 days, 3 and 6 months after surgery 3.1. Domains: Anxiety, Depression 4. Motivational processes at Day of Surgery, 30 days and 3 months after surgery (Intervention only): 4.1. Questionnaires: Behavioural Regulation in Exercise Questionnaire (BREQ), Basic Psychological Need Satisfaction in Exercise Scale (BPNSES), Health Care Climate Questionnaire (HCCQ) 5. Physical status assessed by the incremental shuttle walk test (ISWT) at Baseline and 30 days after surgery; sit-to-stand test and hand grip test at Baseline, Day of Surgery, Day of Discharge and 30 days after surgery. 6. Nutritional assessment including weight (PG-SGA (SF)) at Baseline, Day of Surgery and 30 days after surgery. Health Economic Outcomes 7. Health-related quality of life (EORTC-QLQ-C30, LC-29 and EQ-5D-5L) at Baseline, Day of Surgery, 30 days, 3 and 6 months after surgery 8. Health resource usage at 30 days and 6 months after surgery Previous secondary outcome measures: 1. Days Alive and at Home Within 30 days (DAH30) 2. Patient-reported quality of life (using the EORTC-QLQ-C30 & LC 29) at 14 days, 30 days, 3 and 6 months after surgery 3. Mental health/well-being (using the Hospital Anxiety and Depression Scale (HADS)) at 14 days, 30 days, 3 and 6 months after surgery 4. Symptom score (using a 0-10 point VAS) (intervention only) at baseline. 5. Motivational processes measured using a motivational processes and shortened scale of behavioural change questionnaires at the day of surgery, 30 days and 3 months 6. Physical status assessed by the incremental shuttle walk test (ISWT) at baseline and 30 days, sit-to-stand test and hand grip test at baseline, day of surgery, day of discharge and 30 days. 7. Patient-generated subjective global assessment short form (PG-SGA SF) at baseline, day of surgery and 30 days. Health Economic Outcomes 8. Health-related quality of life (EORTC-QLQ-C30, LC-29 and EQ-5D-5L) at 14 days, 30 days, 3 and 6 months after surgery 9. Health resource usage measured using a Health Resource Usage questionnaire at 30 days and 6 months |
| Overall study start date | 01/05/2022 |
| Overall study end date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 902; UK Sample Size: 902 |
| Participant inclusion criteria | 1. Adults aged 18 years or over 2. With a suspected clinical or pathological diagnosis of primary lung cancer 3. Selected for elective curative lung resection 4. Able to undergo F4S.2 intervention for minimum 2 weeks prior to surgery 5. Willing and able to provide informed consent 6. Willing to use F4S app 7. Willing to complete study questionnaires |
| Participant exclusion criteria | 1. Emergency surgery 2. Patients requiring parenteral nutrition |
| Recruitment start date | 12/10/2023 |
| Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Edgbaston
Birmingham
B15 2GW
United Kingdom
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Du Cane Road
London
W12 0HS
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Clydebank
G81 4DY
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Cambridge Biomedical Campus
Cambridge
CB2 0AY
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Sydney Street
London
SW3 6NP
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
University/education
Head of Research Governance and Integrity
Finance Office
Aston Webb, Block B, Room 119
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0) 7814 650003 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Requests for data generated during the F4S-2 study will be considered by the University of Birmingham Clinical Trials Unit (BCTU). Data will typically be available 6 months after the primary publication. Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed by the BCTU Data Sharing Committee in discussion with the CI and, where appropriate (or in absence of the CI) any of the following: the Trial Sponsor, the relevant Trial Management Group (TMG), and independent TSC. Requests can be made to BCTU-Info@adf.bham.ac.uk A formal Data Sharing Agreement (DSA) may be required between respective organisations once the release of the data is approved and before data can be released. Data will be fully de-identified (anonymised) unless the DSA covers the transfer of participant-identifiable information. Any data transfer will use a secure and encrypted method. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 18/04/2023 | 03/05/2023 | No | Yes |
| Protocol file | version 3.0 | 18/04/2023 | 03/05/2023 | No | No |
| HRA research summary | 20/09/2023 | No | No | ||
| Participant information sheet | version 5.0 | 26/09/2023 | 16/10/2023 | No | Yes |
| Participant information sheet | version 6.0 | 18/07/2024 | 24/10/2024 | No | Yes |
| Protocol file | version 4.0 | 05/09/2024 | 24/10/2024 | No | No |
Additional files
Editorial Notes
01/04/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 05/06/2025 to 31/12/2026.
2. The overall study end date was changed from 31/10/2025 to 31/12/2027.
3. The intention to publish date was changed from 01/10/2026 to 01/12/2028.
4. Guy’s and St Thomas NHS Foundation Trust was added to the study participating centres.
24/10/2024: The following changes were made to the study record:
1. Protocol and participant information sheet added.
2. Royal Brompton & Harefield NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Mid and South Essex NHS Foundation Trust and Hull University Teaching Hospitals NHS Trust added as study participating centres.
3. Secondary outcome measures updated.
18/07/2024: Cancer Research UK link added to plain English summary field.
17/06/2024: The following changes were made to the trial record:
1. The study website was changed from https://www.birmingham.ac.uk/F4S-2 to https://www.birmingham.ac.uk/fit4surger2
2. The study participating centres Oxford University Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, The Royal Wolverhampton NHS Trust, Leeds Teaching Hospitals NHS Trust, Golden Jubilee National Hospital (NHS Golden Jubilee), Royal Infirmary of Edinburgh (NHS Lothian), University Hospitals of Leicester NHS Trust, University Hospitals Plymouth NHS Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Royal Papworth Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust were added
02/11/2023: The study participating centres University Hospitals Bristol and Weston NHS Foundation Trust, Imperial College Healthcare NHS Trust were added.
16/10/2023: Participant information sheet uploaded. The recruitment start date was changed from 02/10/2023 to 12/10/2023.
20/09/2023: A link to the HRA research summary was added.
15/09/2023: The recruitment start date was changed from 04/09/2023 to 02/10/2023.
17/07/2023: The recruitment start date was changed from 31/07/2023 to 04/09/2023.
19/06/2023: The recruitment start date was changed from 05/06/2023 to 31/07/2023.
25/04/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
