QOL After SURGERY and ADJUVANT Treatment

NCT06115239 | Not Yet Recruiting

• 1 other identifier: PI 2023 05 1296 - TD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Non-Small-Cell Lung Cancer; EORTC-LC29; Adjuvant Treatment; Pulmonary Resection; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Correlation between the type of surgical procedure performed and postoperative quality of life

  Before surgery, seven days after surgery

• Correlation between the type of surgical approach performed and postoperative quality of life

  Before surgery, seven days after surgery

• Correlation between the occurrence of postoperative complications and a longer hospital stay

  Before surgery, seven days after surgery, before the first dose of adjuvant treatment

• Effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29

  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

• Adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life

  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

Interventions

Questionnaires OTHER

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

Also known as: Surveys

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Hospital Clínico Universitario

Salamanca, 37007, Spain

Location

Related Publications (21)

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Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pablo Fernández Salvador, Nurse

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Nuria M Novoa Valentín, MD, PhD

  University of Salamanca

  STUDY DIRECTOR

• Marta G Fuentes Gago, MD, PhD

  University of Salamanca

  STUDY DIRECTOR

• María B García Cenador, MD, PhD

  University of Salamanca

  STUDY CHAIR

Central Study Contacts

Pablo Fernández Salvador, Nurse

CONTACT

+34 689147857; pfs45@usal.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 2, 2023
• Study Start: May 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After recruitment has finalized

Locations

ES (1)