F4S-2
Research type
Research Study
Full 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
IRAS ID
317416
Contact name
Babu Naidu
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
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.
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.
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.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0079
Date of REC Opinion
18 Apr 2023
REC opinion
Favourable Opinion