Non Small Cell Lung Cancer
Conditions
Keywords
Segmentectomy, Lobectomy, NSCLC, Lung Cancer, PROM, QoL, HRQoL
Brief summary
The goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery. The main questions it aims to answer are: * Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have less postoperative dyspnea than patients that undergo lobectomy? * Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo lobectomy? * Do patients with stage I NSCLC that undergo VATS segmentectomy or lobectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo RATS segmentectomy or lobectomy? Participants already undergoing surgical intervention as part of their regular medical care for resectable lung cancer will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
Interventions
None listed
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.
Exclusion criteria
* Thoracic surgery in the previous year * Neoadyuvant treatment * Failure to complete preoperative questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative dyspnea | It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery. | The postoperative dyspnea score will be calculated from the 33-35 items of the EORTC QLQ-LC29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 29) questionnaire and standardized to a 0-100 score. These items assess dyspnoea in three modalities: during rest, walking and climbing stairs in the preceding week. In each setting dyspnea is quantified from 1 (not at all short or breath) to 4 (very much short of breath), therefore a higher score indicates a higher level of dyspnea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality-Adjusted Life Years (QALYs) | Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery. | Quality-adjusted life years (QALYs) will be calculated by combining survival with health-related quality of life measured using the EuroQol 5-Dimension ( EQ-5D) Questionnaire questionnaire at predefined follow-up time points. Utility scores derived from EQ-5D responses will be used to estimate QALYs using the area-under-the-curve method over the study period. Utility scores typically range from values below 0 (health states considered worse than death) to 1 (perfect health), with higher scores indicating better health status. |
| Physical Functioning | Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery. | Physical functioning will be assessed using the Physical Functioning scale of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) questionnaire. This scale is calculated from items 1-5, which assess limitations in strenuous activities, walking long and short distances, the need to stay in bed or a chair during the day, and the need for assistance with basic daily activities. Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual, with higher scores indicating better physical functioning (100 = best functioning, 0 = worst). |
Countries
Spain
Contacts
CONTACTSara Fra, MD
CONTACTNicolás Moreno, MD, PhD
PRINCIPAL_INVESTIGATORSara Fra, MD
Hospital Universitario Ramón y Cajal
Outcome results
None listed