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.

 

The F4S-2 Trial is open to recruitment. 

Design

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

Health Economic Assessment

  • Health Related quality of life (EORTC-QLQ-C30, LC-29 and EQ-5D-5L) 
  • Health resource usage questionnaire
  • Patient-reported quality of physical function scale recovery (using the EORTC-QLQ-LC30) at 30 days after surgery
  • Surgical complications (using the Comprehensive Complication Index (CCI)) at 30 days after surgery

Setting

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

Target Population

902 patients who are about to undergo lung cancer surgery

Intervention

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.

Measurement of outcomes

Primary Outcomes (dual primaries)

  • Patient-reported quality of physical function scale recovery (using the EORTC-QLQ-LC30) at 30 days after surgery
  • Surgical complications (using the Comprehensive Complication Index (CCI)) at 30 days after surgery

Secondary Outcomes (Baseline, Day of surgery, 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)
  • Motivation Processes (using BREQ, BPNSES and HCCQ) (Intervention only)
  • Physical status assessed by the incremental shuttle walk test (ISWT), sit to stand test and hand grip test
  • Nutritional assessment including weight (PG-SGA (SF))

  Health Economic Assessment

  • Health Related quality of life (EORTC-QLQ-C30, LC-29 and EQ-5D-5L) 
  •  Health resource usage questionnaire

More information...