Fit4Surgery 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
A smartphone app will coach lung cancer patients through tailored exercise and nutrition plans in the weeks before their surgery, then track their recovery afterwards. Lung cancer surgery is a major physical ordeal, and patients who are weak or malnourished beforehand face more complications and slower recoveries. Current pre-surgery care is inconsistent across NHS hospitals, and many patients lack the structured support to improve their fitness before an operation. This trial tests whether a personalised, app-based prehabilitation programme—combining exercise prescriptions, nutritional advice, and symptom tracking—can measurably improve outcomes compared to standard care alone. If the programme works, it could give surgeons and patients a practical, scalable tool to reduce post-surgery complications and speed up physical recovery. The trial will recruit 902 patients across 20 NHS hospitals, measuring complications using the Comprehensive Complication Index and patient-reported physical function at 30 days after surgery. A health economic analysis will determine whether the app saves the NHS money by shortening hospital stays and reducing readmissions. If cost-effective, this approach could become a routine part of lung cancer surgical pathways nationwide.
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Fit4Surgery 2: Can an App-based, motivation-theory grounded, personalised, comprehensive, prehabilitation programme enhance recovery of physical function and reduce complications after lung cancer surgery compared to usual care DESIGN Pragmatic, multicentre, open label, randomised controlled, two arm, parallel group, (non-CTIMP) trial with an internal pilot and health economic evaluation. Progression criteria from pilot to main study will be assessed on (a) recruitment and (b) protocol adherence. SETTING 20 UK NHS acute hospitals mixed Cardiothoracic and Thoracic centres TARGET POPULATION Adult patients (age > 18) newly diagnosed with lung cancer referred for curative lung cancer surgery RANDOMISATION Randomisation will occur once the patient fulfils the eligibility criteria and following written informed consent. A computer-generated randomisation sequence will be generated by the minimisation method and patients will be randomised in a ratio of 1:1 to F4S-2: Usual Care. INTERVENTION GROUP STRUCTURED EXERCISE PROGRAMME - patient tailored, range of strengthening, mobility and cardiovascular exercises to be completed at least twice a week. Heart rate is recorded using a wearable sensor and used as bio-feedback and to support individualised goal setting INDIVIDUALISED NUTRITIONAL CONDITIONING - Patients complete a nutritional screening questionnaire within the App which is used to tailor nutritional advice and supplements PERSONALISED HEALTH INFORMATION is displayed in the App guided by symptom data collected within the App. CONTROL GROUP Usual care as per the standard perioperative pathways at each site DUAL PRIMARY OUTCOMES •Comprehensive Complication Index (CCI) at 30-day after surgery •Patient-reported quality of physical function recovery measured by 30-item quality of life questionnaires (EORTC- QLQ-C30) 30 days after surgery SECONDARY OUTCOMES •Clinical outcomes: initial postoperative hospital length of stay and length of stay related to any readmissions •Health related quality of life 1. EORTC- QLQ-C30 (at 6mo) & LC-13 (lung cancer) 2. EuroQol five dimensions questionnaire {EQ-5D-5L} •Mental health/well-being 1. Hospital Anxiety and Depression Scale 2. Subjective Vitality Scale •Physical Status 1. Nutritional status (weight and score change) 2. Exercise capacity (incremental shuttle walk test) 3. Muscle strength (hand grip) •Economic analysis Within-trial and supplementary model-based economic analyses will determine the cost-effectiveness of F4S-2 as compared to usual care. SAMPLE SIZE 902 participants (451 in each arm) PROJECT TIMETABLE Months: 1-6 set-up 7-30 recruitment (with embedded 6-month pilot) 31-36 follow-up and data return 37-42 data cleaning, analysis, close out and publication STUDY WITHIN A TRIAL will investigate using a mixed method survey why patients who decline to participate in the clinical trial make this decision EXPERTISE IN TEAM The co-applicant group comprises experts in clinical trials with a track record of successful completion of publicly funded research and clinicians who are recognised national experts in lung cancer prehabilitation, exercise psychology/behaviour change and nutrition. Our 2 PPI co-applicants are experienced in contributing to lung cancer studies and have lived experience of both condition and treatment.
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