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)

Abstract

Background: Lung cancer is increasingly a disease of the elderly and frail population with a median age of 70 years at diagnosis. Therefore, consideration of the impact of interventions on health-related quality of life (HRQOL) and not only absolute survival is especially important. For non-small cell lung cancer (NSCLC), video-assisted thoracoscopic surgery (VATS) has been gaining popularity over the last few decades, replacing traditional open lobectomies. For high-risk patients who are not deemed suitable for surgery, stereotactic ablative body radiotherapy (SABR) provides a potentially curative alternative. However, little is known about how VATS and SABR affect HRQOL measured using patient reported outcome measures (PROMs). The LiLAC study (Life after Lung Cancer) aims to explore HRQOL following intervention with VATS or SABR using validated PROMs and to pilot the use of an online questionnaire system (QTool) in this setting. We hope the results will aid both patients and clinicians in decision making and improve the management of post-intervention problems.Methods: In total, 300 patients (150 VATS and 150 SABR) patients will be recruited over the study period.Patients will be approached prior to intervention and asked to complete baseline HRQOL questionnaires.They will be given access to the QTool online system and then in the 12 months following intervention will be asked to complete questionnaires (paper or online) at 4-time points. Answers will available for patients and clinicians to view throughout the study period. Clinical information (age, gender, co-morbidity, current medications and smoking status along with treatment-specific information) will also be collected. Primary outcome will be to detect changes of PROs (HRQOL and patient satisfaction) after VATS lung resections or SABR in early stage lung cancer patients. Secondary outcomes include correlation of patient's clinical data with HRQOL results to identify predictors of poor outcomes and exploration of patient and clinician views on the usefulness of QOL measurements.Discussion: (I) This first study will primarily compare multiple patients reported outcomes for 12 months after VATS lobectomy and SABR in early stages NSCLC patients. We will explore the acceptability of an online assessment of the HRQOL in NSCLC patients. (II) The study is also focused on the patients' opinion during the shared decision-making process, which has rarely been investigated in surgical lung cancer 2704 Pompili et al. LiLAC: life after lung cancer

Patients’ confidence in treatment decisions for early stage non-small cell lung cancer (NSCLC)

“…The most effective treatment options for curative lung cancer are video assisted thoracoscopic (VATS) resection or stereotactic ablative body radiotherapy (SABR) for patients unfit for surger. The treatment effectiveness is evaluated on survival data (1,2) and presently there is little information about the effects of these treatments on patients' quality of life (QOL) (3,4). About 44% of patients diagnosed with lung cancer are aged 75 and over (5) and commonly have multiple comorbidities with 54% presenting with three or more (6) reducing their eligibility for surgery (6,7).…”

Patients’ confidence in treatment decisions for early stage non-small cell lung cancer (NSCLC)

“…This study assesses the utility of a patient reported measure of decision making confidence carried out as part of the Life after Lung Cancer (LiLAC) study [4]. LiLAC used validated Patient-reported outcome measures (PROMs) to describe the trajectory of Quality of Life (QoL) following VATS or SABR treatment.…”

“…The most effective treatment options for curative lung cancer are video assisted thoracoscopic (VATS) resection or stereotactic ablative body radiotherapy (SABR) for patients unfit for surgery. The treatment effectiveness is evaluated on survival data [ 1 , 2 ] and presently there is little information about the effects of these treatments on patients’ quality of life (QoL) [ 3 , 4 ]. About 44% of patients diagnosed with lung cancer are aged 75 and over [ 5 ] and commonly have multiple comorbidities with 54% presenting with three or more [ 6 ] reducing their eligibility for surgery [ 6 , 7 ].…”

Shared Decision Making in Early-Stage Non-small Cell Lung Cancer: A Systematic Review

“…[3,4] Patient and clinician prior preferences between surgical and SABR treatments and the need for involvement in decisions have been challenges for NSCLC clinical trials. [5,6] When clinical outcomes after surgery or SABR are not easily comparable, it is vital to involve patients in decision-making, discussing the reasons for pre-existing patient, and clinician, preferences, can support the shared decision making process, and may improve satisfaction. [7] This systematic review critically evaluates studies of patient and clinician preferences for treatment of early stage NSCLC to explore:…”