Lung CancerLILACNCT02882750
Effect on Patient Reported Outcomes of VATS and SABR (LILAC)
An observational study of Lung Cancer, run by University of Leeds.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EORTC QLQ-C30 (version 3.0)., PS Q18 and Decision Self-Efficacy Scale
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2016to 6 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early stage Non-Small Cell Lung Cancer patients
Who may be able to join
- 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.
Who cannot join
- Advanced diseases (III-IV stages).
- Patient included in other HRQoL study, which may increase patient burden and bias the answer of the questionnaires.
About this study
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)
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:
- Differences after VATS resections or SABR in terms of physical and psychological symptoms, quality of life and satisfaction
- Patient perspectives of the Shared Decision Making Process.
Read the detailed description
- 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.
- 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
- Being tested
- EORTC QLQ-C30 (version 3.0)., PS Q18, Decision Self-Efficacy Scale
- Keywords
- Lung Cancer, Quality of Life, VATS, SABR
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-C30 (version 3.0).Other
Quality of Life Questionnaire
PS Q18Other
Patients Satisfaction Questionnaire
Decision Self-Efficacy ScaleOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients | Early stage NSCLC patients submitted to Surgical Resection Receives: Other: EORTC QLQ-C30 (version 3.0).; Other: PS Q18; Other: Decision Self-Efficacy Scale | |
| SABR Patients | Early stage NSCLC patients submitted to SABR Receives: Other: EORTC QLQ-C30 (version 3.0).; Other: PS Q18; Other: Decision Self-Efficacy Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Reported Outcomes
Quality of life (EORTC QLQ-C30 and LC13 questionnaire)
Measured: 12 months
Secondary outcomes (4)
Decision self-efficacy scale
Patient perspectives of the Shared Decision Making Process.
Measured: 3 months
Patient Acceptability
Patient acceptability explored through interviews
Measured: 12 months
Clinician Acceptability
clinician acceptability explored through interviews
Measured: 12 months
Patients satisfaction
patients satisfaction of the care received (PSQ-18 Patient satisfaction questionnaire)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start25 Jan 2016
- Primary completion9 Apr 2018
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Yorkshire Cancer Research, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Galina Velikova, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882750
- Sponsor's protocol ID
- L399
- Acronym
- LILAC
- Status last verified
- Nov 2019
- First submitted
- 7 Jul 2016
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28932579
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02882750
- Acronym / sponsor ID
- LILAC / L399
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Quality of Life, VATS, SABR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Yorkshire Cancer Research, The Leeds Teaching Hospitals NHS Trust
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Differences after VATS resections or SABR in terms of physical and psychological symptoms, quality of life and satisfaction
- Patient perspectives of the Shared Decision Making Process.
Detailed description
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients | – | Other: EORTC QLQ-C30 (version 3.0)., Other: PS Q18, Other: Decision Self-Efficacy ScaleEarly stage NSCLC patients submitted to Surgical Resection |
| SABR Patients | – | Other: EORTC QLQ-C30 (version 3.0)., Other: PS Q18, Other: Decision Self-Efficacy ScaleEarly stage NSCLC patients submitted to SABR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early stage Non-Small Cell Lung Cancer patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Advanced diseases (III-IV stages).
- Patient included in other HRQoL study, which may increase patient burden and bias the answer of the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-C30 (version 3.0).Quality of Life Questionnaire | Other | SABR Patients, Surgical Patients |
| PS Q18Patients Satisfaction Questionnaire | Other | SABR Patients, Surgical Patients |
| Decision Self-Efficacy ScaleQuestionnaire | Other | SABR Patients, Surgical Patients |
Primary outcome
Patients Reported Outcomes
Time frame: 12 months
Quality of life (EORTC QLQ-C30 and LC13 questionnaire)
4 secondary outcomes
Decision self-efficacy scale
Time frame: 3 months
Patient Acceptability
Time frame: 12 months
Clinician Acceptability
Time frame: 12 months
Patients satisfaction
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 28932579Pompili 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Reported Outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.