Effect on Patient Reported Outcomes of VATS and SABR (LILAC)

• Methods

Aim and Objectives

This study aims to describe the trajectory of lung cancer patients HRQoL, symptoms and functions following VATS or SABR treatment for Stage I-II NSCLC and to determine the feasibility and patient acceptability of online self-reporting of PROMs.

Specific objectives of the study include:

• To compare changes before and after treatment of patient reported outcomes (HRQOL and Patient Satisfaction) after VATS lung resections or SABR in early stage lung cancer patients.
• To correlate clinical outcomes (complications and AEs) with Quality of Life in order to find objective predictors of major decline in patient reported outcomes.
• To identify specific factors, which have influenced the personal choice between the treatments (Decision Self-Efficacy Scale)
• Establish recruitment and attrition rates and adherence to PROMs reporting during the study
• To describe patient choice of electronic vs paper questionnaires
• To explore implementation issues through patient and staff interview.
• Design

This is an observational prospective longitudinal study with repeated measures (PROMs), employing a convenience sample of consecutive patients planned to have VATS resections or SABR for stages I-II of NSCLC. Outcomes measures will be collected prior to treatment and 1,3,6,12 months afterwards, administering the questionnaires by the remote web-based system. Paper administration will be offered to patients without Internet access.

Sample size considerations

Last year 100 pre-surgical quality of life questionnaires have been collected in 5 months from outpatients' clinic at Leeds Cancer Centre (LCC). For longitudinal studies involving regular PROMs, the investigators typically see 70% consent rate and 30-35% attrition over 3 months24. Therefore the investigators expectations are to be able to recruit 200 VATS and 50 SABR patients recruiting over 12 months with 12 months of follow-up.

In order to detect a minimum difference of 10% from the baseline value and standard deviation of the EORTC QLQ-C30 Global Health Scale scale (as measured in our historical cohort of 115 anatomic lung resections), with a alfa level of 0.05 and statistical power of 90%, a sample size of 115 patients in the surgical arm was estimated.

Inclusion criteria

• Age 18 years and over.
• Diagnosis of NSCLC either from histology or MDT/Tumour Board agreement on >95% likelihood of diagnosis based on radiological evidence or both.
• Decision for either surgery or SABR
• Able to give informed consent.
• Able to understand the language of the questionnaire.
• There will be no limit on performance status.

Exclusion criteria

• Advanced diseases (III-IV stages).
• Patient included in other HRQoL study, which may increase patient burden and bias the answer of the questionnaires.