QOL After SURGERY and ADJUVANT Treatment

Quality of Life Clinical Trial

Official title:

Evaluation of Changes in Quality of Life in Patients With Non-small Cell Lung Carcinoma Undergoing Lung Resection Before and After Receiving Adjuvant Treatment Using the EORTC-LC29 Questionnaire

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115239
• Other study ID #: PI 2023 05 1296 - TD
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: University of Salamanca
• Contact: Pablo Fernández Salvador, Nurse
• Phone: +34 689147857
• Email: pfs45[@]usal.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:

Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection

Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.

Description:

Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.

As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.

It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.

Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: 50-85 years old

• Patients with any histological type of non-small-cell lung cancer in clinical stage T1C N0M0 or greater

• Patients that understand the purpose of the study, accept collaborate and sign the informed consent.

Exclusion Criteria:

• Patients not receiving adjuvant treatment due to complications, bad quality of life or express rejection at any moment of the curse of the process.

• Patients who cannot complete the previous questionnaires to assess their quality of life

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Quality of Life

Intervention

Other:
• Questionnaires
The patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life before and after adjuvant treatment in patients undergoing pulmonary resection	For quality of life assessment, patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).	Pre-surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Secondary	Correlation between the type of surgical procedure performed and postoperative quality of life	Measure and analyze the correlation between the type of surgical procedure performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical procedure (segmentectomy, lobectomy or pneumonectomy), will be collected from the post-surgery report.	Before surgery, seven days after surgery
Secondary	Correlation between the type of surgical approach performed and postoperative quality of life	Measure and analyze the correlation between the type of surgical approach performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical approach (thoracotomy, VATS or RATS), will be collected from the post-surgery report.	Before surgery, seven days after surgery
Secondary	Correlation between the occurrence of postoperative complications and a longer hospital stay	Analyze the correlation between the occurrence of postoperative complications and a longer hospital stay with the quality of life before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Post-surgery complications will be collected from the patient's medical record, recorded in the Jimena 4 software program. Hospital stay lenght will be collected from the patient´s hospital discharge report.	Before surgery, seven days after surgery, before the first dose of adjuvant treatment
Secondary	Effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29	Measure and analyze the effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29 for patients undergoing lung resection for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC), where higher score represents higher level of symptomatology or problems.	Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Secondary	Adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life	Measure and analyze whether any adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life of patients who receive adjuvant treatment after undergoing lung resection compared to others.	Before the first cycle of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Secondary	Correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life	Analyze the correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life upon completion of the surgical episode before and after receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).	Before surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Secondary	Level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment	Measure and analyze the level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment for lung cancer. Patients will be asked to complete the HADS questionnaire.	Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Secondary	Effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality.	Measure and analyze the effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Performance Status Score and ECOG score data will be collected from the patient's medical record, recorded in the Jimena 4 software program.	Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment

External Links

•   6th LuCE Report on lung cancer. Experiences and quality of life of people impacted by lung cancer in Europe