Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Location status: Recruiting
Location contact
Nicolás Moreno, PhD
CONTACT
Sara Fra, MD
CONTACT
NCT Number: NCT07477158
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Madrid, 28034, Spain
Location status: Recruiting
Nicolás Moreno, PhD
CONTACT
Sara Fra, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Nicolás Moreno, MD, PhD
CONTACT
Sara Fra, MD
CONTACT
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Other
Living After Lung Surgery: Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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