Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.

Disqualifiers

Thoracic surgery in the previous year

Neoadyuvant treatment

Failure to complete preoperative questionnaires

Trial population

Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 2 trial groups
Group A: Segmentectomy
Group B: Lobectomy

Trial outcomes

Primary outcomes

1

Postoperative dyspnea

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
It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.

Secondary outcomes

1

Quality-Adjusted Life Years (QALYs)

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.
2

Physical Functioning

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).

Time frame
Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.

Other outcomes

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