LILAC: Effect on Patient Reported Outcomes of Surgery and SABR (V 1.0)
Research type
Research Study
Full 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)
IRAS ID
209626
Contact name
Galina Velikova
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Background
Lung cancer is the most common cancer in Yorkshire, with around 4,500 people diagnosed with the disease every year. The Key-hole surgery (VATS) is becoming the standard of care for stages I-II Non-small cell lung cancer (NSCLC). Focused Radiotherapy (SABR) is an accepted alternative for medically inoperable patients. Patient preferences influencing the decision to proceed to one of these treatments have not been investigated.Aims and Objectives
In the current study we plan to evaluate the Lung Cancer treatments from the patient’s perspective. We will examine acceptability and adherence to the patient’s reported outcomes collection during their trajectory of early-stages Non-Small Cell Lung Cancer.Study sample and research design
This is an observational prospective longitudinal study with repeated measures (PROMs), on adult consecutive patients in St James’ University Hospital Bexley Wing planned to have VATS resections or SABR for stages I-II of NSCLC. Outcomes measures will be collected prior to treatment and 6 weeks,3, 6 & 12 months afterwards, administering the questionnaires by the remote with the help of an existing electronic patient portal in Leeds for self-reporting of symptoms or adverse treatment effects. Paper administration will be offered to patients without Internet access.In particular, we will:
- Detect changes in daily quality of life before and through all the first year after treatments.
- Better understand how patient has been involved in making an informed choice and their satisfaction with care received.
- Find any correlation between clinical parameters and changes in Quality of Life.Study measures
We will assess overall quality of life using validated questionnaire and appropriate subscales (e.g. EORTCQLQC30 and LC13). We will evaluate Patients Satisfaction and Patients opinion ions about the decision-making process by validated questionnaires (PSQ-18 and Decision Self-Efficacy Scale).Patient and staff interviews
Semi structured staff, patients and carer interviews will be conducted to explore experiences of participating to the LILAC study and any recommendations for improvement.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0407
Date of REC Opinion
12 Oct 2016
REC opinion
Favourable Opinion