Title: 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
Funder: Department of Health and Social Care

Abstract: Around 7000 patients undergo curative lung cancer surgery each year in the UK. These numbers are rising annually as advances in surgical techniques mean that operations can now be offered to older and less fit patients. Unfortunately there has not been a parallel improvement in outcomes following surgery; nearly half of patients develop complications after surgery which can significantly impact upon quality of life and reduce long term survival rates after surgery. Such complications may negate any potential benefits from the surgical procedure. _x000D_ Exercise programmes before lung surgery have been shown to improve patients’ physical fitness thereby reducing complications and time in hospital as well enhancing recovery after surgery. Similarly, nutritional supplements taken before and/or after surgery are known to improve recovery and add to the benefits of structured exercise programmes. Despite clear evidence for the benefits of ‘prehabilitation’, access to such programmes is extremely limited in the UK for logistical, administrative and financial reasons. _x000D_ Our team has already created and piloted App-based programmes in the provision of pre-operative information, exercise and nutrition, specifically designed to prepare patients for lung surgery and improve their recovery. We have combined these into a new App called ‘Fit4Surgery 2’. This App supports individualised exercises for patients who can design a programme appropriate to their own fitness level, capacity and preferences. Videos demonstrate a range of strengthening, mobility, and cardiovascular exercises. Data collected within the App (including heart rate measured by a wearable device) are uploaded electronically. Clinicians have access to a web based portal with a summary of their patient’s progress. Personalised health information is also presented based on patient symptoms. Repeated nutritional assessments within the App allow for personalised nutritional advice. Embedded within the App are strategies to enhance motivation/adherence. _x000D_ We believe that having access to the Fit4Surgery 2 App would enhance uptake and engagement with prehabilitation programmes by breaking down geographic, logistical and time related barriers which hamper the limited systems currently available. This would manifest in improved recovery, reflected by improved quality of life and a reduction in number and impact of complications after lung cancer surgery._x000D_ In this study we will recruit 902 patients due to undergo lung cancer surgery and randomly allocate them to receive either the Fit4Surgery 2 App or Usual Care. Data will be collected on patient recovery, complication rates and quality of life measures at up to 6 months after surgery._x000D_ Our patient Co-applicants RK and JR, both have lived experience of lung cancer surgery, and have been actively involved in the intervention’s development. Interviews and questionnaires have been used to gather lung patients’ experiences during the design process and a national group of patients and carers advised on appropriate outcome measures for the trial._x000D_ The findings will be published in major medical and behavioural science journals, presented in national scientific meetings and made available online to NHS professionals and policy makers, medical/healthcare societies and charities, and patient support groups. Plain English summaries of the trial findings will be available for patients.

Lay abstract: 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_x000D_ _x000D_ DESIGN _x000D_ 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._x000D_ _x000D_ SETTING_x000D_ 20 UK NHS acute hospitals mixed Cardiothoracic and Thoracic centres _x000D_ _x000D_ TARGET POPULATION_x000D_ Adult patients (age > 18) newly diagnosed with lung cancer referred for curative lung cancer surgery_x000D_ _x000D_ RANDOMISATION_x000D_ 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. _x000D_ _x000D_ INTERVENTION GROUP_x000D_ 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_x000D_ INDIVIDUALISED NUTRITIONAL CONDITIONING - Patients complete a nutritional screening questionnaire within the App which is used to tailor nutritional advice and supplements _x000D_ PERSONALISED HEALTH INFORMATION is displayed in the App guided by symptom data collected within the App._x000D_ _x000D_ CONTROL GROUP _x000D_ Usual care as per the standard perioperative pathways at each site _x000D_ _x000D_ DUAL PRIMARY OUTCOMES _x000D_ •Comprehensive Complication Index (CCI) at 30-day after surgery_x000D_ •Patient-reported quality of physical function recovery measured by 30-item quality of life questionnaires (EORTC- QLQ-C30) 30 days after surgery_x000D_ _x000D_ SECONDARY OUTCOMES _x000D_ •Clinical outcomes: initial postoperative hospital length of stay and length of stay related to any readmissions_x000D_ _x000D_ •Health related quality of life _x000D_ 1. EORTC- QLQ-C30 (at 6mo) & LC-13 (lung cancer) _x000D_ 2. EuroQol five dimensions questionnaire {EQ-5D-5L} _x000D_ _x000D_ •Mental health/well-being _x000D_ 1. Hospital Anxiety and Depression Scale_x000D_ 2. Subjective Vitality Scale_x000D_ _x000D_ •Physical Status _x000D_ 1. Nutritional status (weight and score change) _x000D_ 2. Exercise capacity (incremental shuttle walk test)_x000D_ 3. Muscle strength (hand grip) _x000D_ _x000D_ •Economic analysis Within-trial and supplementary model-based economic analyses will determine the cost-effectiveness of F4S-2 as compared to usual care. _x000D_ _x000D_ SAMPLE SIZE_x000D_ 902 participants (451 in each arm)_x000D_ _x000D_ PROJECT TIMETABLE _x000D_ Months: _x000D_ 1-6 set-up _x000D_ 7-30 recruitment (with embedded 6-month pilot) _x000D_ 31-36 follow-up and data return _x000D_ 37-42 data cleaning, analysis, close out and publication _x000D_ _x000D_ STUDY WITHIN A TRIAL will investigate using a mixed method survey why patients who decline to participate in the clinical trial make this decision _x000D_ _x000D_ EXPERTISE IN TEAM_x000D_ 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.

Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS