Fit4Surgery-2

A pragmatic, multicentre, open-label, randomised controlled, two arm, parallel group trial with an internal pilot, an embedded SWAT, and health economic evaluation.

Primary Objectives:

●        To establish the clinical and cost-effectiveness of the F4S App, a digital platform prehabilitation programme, consisting of personalised health information, a structured exercise programme and tailored nutritional conditioning in lung cancer surgery patients, in addition to usual care, when compared to usual care alone.

Secondary Objectives:

●        To examine the impact of prehabilitation on the overall quality of life and the mental health of the participant

●        To use patient-submitted data to explore the trajectory of recovery with reference to muscle strength, physical endurance, nutritional status, symptoms and activities.

Economic Objectives

To establish cost-effectiveness of F4S compared to usual care, expressed as quality-adjusted life years (QALY).

20 UK NHS acute hospitals; mixed Cardiothoracic and Thoracic hospitals performing lung cancer surgery

902 patients who are about to undergo lung cancer surgery

The F4S App & usual care versus usual care 

The F4S App collects baseline demographic data, comorbidities, symptom burden using simple questions and Visual Analogue Scales (VAS), and the outcome measures of Quality of Life, Health and wellbeing scores.

The 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.

Individualised nutritional conditioning

Personalised health information - Short informational videos are displayed within the App.  Information is responsive, and guided by symptom data.

Primary Outcomes (dual primaries)

 

●        Patient-reported quality of physical function scale recovery (using the EORTC-QLQ-LC29) at 30 days after surgery

●        Surgical complications (using the Comprehensive Complication Index (CCI)) at 30 days after surgery

 

Secondary Outcomes (Baseline, Day of surgery, 14 Days, 30 Days, 3 and 6 Months after surgery)

 

●        Days Alive and at Home Within 30 days (DAH30)

●        Quality of Life (using the EORTC-QLQ-C30, LC29)

●        Mental health/well-being (using the HADS)

●        Symptom score (using a VAS)

●        Motivation Processes

●        Physical status assessed by the incremental shuttle walk test (ISWT), sit to stand test and hand grip test

●        Patient-generated subjective global assessment short form (PG-SGA SF)

 

Health Economic Assessment

·         Health Related quality of life (EORTC-QLQ-C30, LC-29 and EQ-5D-5L) 

·         Health resource usage