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

Lung Cancer Clinical Trial

— LILAC  

Official title:

Curative Treatment Modalities of Early Stages Non-Small Cell Lung Cancer: Effect on Patient Reported Outcomes of Video Assisted Thoracoscopic (VATS) Resection and Stereotactic Ablative Body Radiotherapy (SABR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882750
• Other study ID #: L399
• Status: Completed
• Start date: January 25, 2016
• Est. completion date: June 6, 2019

Study information

• Verified date: November 2019
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with this information the Shared Decision Making (SDM) process.

300 consecutive patients will be followed up from prior the treatment to 12 months afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18, Decision Self-Efficacy Scale) by a remote web-based system.

Deliverable:

1. Differences after VATS resections or SABR in terms of physical and psychological symptoms, quality of life and satisfaction

2. Patient perspectives of the Shared Decision Making Process.

Description:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: June 6, 2019
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• EORTC QLQ-C30 (version 3.0).
Quality of Life Questionnaire
• PS Q18
Patients Satisfaction Questionnaire
• Decision Self-Efficacy Scale
Questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Leeds	The Leeds Teaching Hospitals NHS Trust, Yorkshire Cancer Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Reported Outcomes	Quality of life (EORTC QLQ-C30 and LC13 questionnaire)	12 months
Secondary	Decision self-efficacy scale	Patient perspectives of the Shared Decision Making Process.	3 months
Secondary	Patient Acceptability	Patient acceptability explored through interviews	12 months
Secondary	Clinician Acceptability	clinician acceptability explored through interviews	12 months
Secondary	Patients satisfaction	patients satisfaction of the care received (PSQ-18 Patient satisfaction questionnaire)	1 month