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

NCT ID: NCT02882750

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 244 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-25
• Study Completion Date: 2019-06-06

Brief 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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgical Patients

Early stage NSCLC patients submitted to Surgical Resection

EORTC QLQ-C30 (version 3.0).

Intervention Type: OTHER

Quality of Life Questionnaire

PS Q18

Intervention Type: OTHER

Patients Satisfaction Questionnaire

Decision Self-Efficacy Scale

Intervention Type: OTHER

Questionnaire

SABR Patients

Early stage NSCLC patients submitted to SABR

EORTC QLQ-C30 (version 3.0).

Intervention Type: OTHER

Quality of Life Questionnaire

PS Q18

Intervention Type: OTHER

Patients Satisfaction Questionnaire

Decision Self-Efficacy Scale

Intervention Type: OTHER

Questionnaire

Interventions

EORTC QLQ-C30 (version 3.0).

Quality of Life Questionnaire

Intervention Type: OTHER

PS Q18

Patients Satisfaction Questionnaire

Intervention Type: OTHER

Decision Self-Efficacy Scale

Questionnaire

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yorkshire Cancer Research

OTHER

Sponsor Role: collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Galina Velikova

Prof of Clinical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Pompili C, Franks KN, Brunelli A, Hussain YS, Holch P, Callister ME, Robson JM, Papagiannopoulos K, Velikova G. Patient reported outcomes following video assisted thoracoscopic (VATS) resection or stereotactic ablative body radiotherapy (SABR) for treatment of non-small cell lung cancer: protocol for an observational pilot study (LiLAC). J Thorac Dis. 2017 Aug;9(8):2703-2713. doi: 10.21037/jtd.2017.07.35.

Reference Type: DERIVED

PMID: 28932579 (View on PubMed)

Other Identifiers

L399

Identifier Type: -

Identifier Source: org_study_id