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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02882750
Acronym
LILAC
Enrollment
244
Registered
2016-08-30
Start date
2016-01-25
Completion date
2019-06-06
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung Cancer, Quality of Life, VATS, SABR

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.

Interventions

OTHEREORTC QLQ-C30 (version 3.0).

Quality of Life Questionnaire

OTHERPS Q18

Patients Satisfaction Questionnaire

OTHERDecision Self-Efficacy Scale

Questionnaire

Sponsors

Yorkshire Cancer Research
CollaboratorOTHER
The Leeds Teaching Hospitals NHS Trust
CollaboratorOTHER
University of Leeds
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patients Reported Outcomes12 monthsQuality of life (EORTC QLQ-C30 and LC13 questionnaire)

Secondary

MeasureTime frameDescription
Decision self-efficacy scale3 monthsPatient perspectives of the Shared Decision Making Process.
Patient Acceptability12 monthsPatient acceptability explored through interviews
Clinician Acceptability12 monthsclinician acceptability explored through interviews
Patients satisfaction1 monthpatients satisfaction of the care received (PSQ-18 Patient satisfaction questionnaire)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026