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

NCT02882750 | Completed

• 1 other identifier: L399
• Study Type: observational
• Target: 244
• Locations: 0 countries
• Sites: N/A

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. 1.Differences after VATS resections or SABR in terms of physical and psychological symptoms, quality of life and satisfaction
2. 2.Patient perspectives of the Shared Decision Making Process.

Conditions

Lung Cancer

Keywords

Lung Cancer; Quality of Life; VATS; SABR

Outcome Measures

Primary Outcomes (1)

• Patients Reported Outcomes

  Quality of life (EORTC QLQ-C30 and LC13 questionnaire)

  12 months

Secondary Outcomes (4)

• Decision self-efficacy scale

  3 months

• Patient Acceptability

  12 months

• Clinician Acceptability

  12 months

• Patients satisfaction

  1 month

Study Arms (2)

Surgical Patients

Early stage NSCLC patients submitted to Surgical Resection

Other: EORTC QLQ-C30 (version 3.0).; Other: PS Q18; Other: Decision Self-Efficacy Scale

SABR Patients

Early stage NSCLC patients submitted to SABR

Other: EORTC QLQ-C30 (version 3.0).; Other: PS Q18; Other: Decision Self-Efficacy Scale

Interventions

EORTC QLQ-C30 (version 3.0). OTHER

Quality of Life Questionnaire

SABR Patients; Surgical Patients

PS Q18 OTHER

Patients Satisfaction Questionnaire

SABR Patients; Surgical Patients

Decision Self-Efficacy Scale OTHER

Questionnaire

SABR Patients; Surgical Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Early stage Non-Small Cell Lung Cancer patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Leeds: lead
• Yorkshire Cancer Research: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Related Publications (1)

• 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.

  PMID: 28932579 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Clinical Oncology

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: August 30, 2016
• Study Start: January 25, 2016
• Primary Completion: April 9, 2018
• Study Completion: June 6, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11