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QOL After SURGERY and ADJUVANT Treatment

U

University of Salamanca

Status

Not yet enrolling

Conditions

Quality of Life
Carcinoma, Non-Small-Cell Lung

Treatments

Other: Questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT06115239
PI 2023 05 1296 - TD

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Pablo Fernández Salvador, Nurse

Data sourced from clinicaltrials.gov

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