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Trial Title:
QOL After SURGERY and ADJUVANT Treatment
NCT ID:
NCT06115239
Condition:
Carcinoma, Non-Small-Cell Lung
Quality of Life
Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-Small-Cell Lung Cancer
EORTC-LC29
Adjuvant Treatment
Pulmonary Resection
Quality of Life
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Questionnaires
Description:
The patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments.
Other name:
Surveys
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.
Detailed 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.
Criteria for eligibility:
Study pop:
The study population will be formed by patients undergoing pulmonary resection because of
lung cancer that are candidates of taking adjuvant treatment after surgery. The patients
will be collected from the Thoracic Surgery Department of Hospital Clínico Universitario
de Salamanca
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clínico Universitario
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Start date:
May 2024
Completion date:
January 2026
Lead sponsor:
Agency:
University of Salamanca
Agency class:
Other
Source:
University of Salamanca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06115239
https://www.lungcancereurope.eu/wp-content/uploads/2022/06/6th-LuCE-Report_Web-version_Definitive.pdf
