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

November 2, 2019 updated by: Galina Velikova, University of Leeds

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Early stage Non-Small Cell Lung Cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Patients
Early stage NSCLC patients submitted to Surgical Resection
Other: EORTC QLQ-C30 (version 3.0).
Quality of Life Questionnaire
Other: PS Q18
Patients Satisfaction Questionnaire
Other: Decision Self-Efficacy Scale
Questionnaire
SABR Patients
Early stage NSCLC patients submitted to SABR
Other: EORTC QLQ-C30 (version 3.0).
Quality of Life Questionnaire
Other: PS Q18
Patients Satisfaction Questionnaire
Other: Decision Self-Efficacy Scale
Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Reported Outcomes
Time Frame: 12 months
Quality of life (EORTC QLQ-C30 and LC13 questionnaire)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision self-efficacy scale
Time Frame: 3 months
Patient perspectives of the Shared Decision Making Process.
3 months
Patient Acceptability
Time Frame: 12 months
Patient acceptability explored through interviews
12 months
Clinician Acceptability
Time Frame: 12 months
clinician acceptability explored through interviews
12 months
Patients satisfaction
Time Frame: 1 month
patients satisfaction of the care received (PSQ-18 Patient satisfaction questionnaire)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust
Yorkshire Cancer Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2016

Primary Completion (Actual)

April 9, 2018

Study Completion (Actual)

June 6, 2019

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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