Quality of Life as a Predictor of OS and PFS in Patients With Lung Cancer

NCT06900283 | Active Not Recruiting DMC

• 2 other identifiers: C19010300492 - FACT-LC19010300492
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

By 2020, lung cancer continues leading the first cause of cancer mortality and the second most common type of cancer in the world. There are limitations to early detection and then more than 60% of patients are diagnosed in advanced stages where there are no longer curative options; that situation is associated with high mortality and poor survival. It is known that some clinical and biochemical parameters of the disease have been recognized as prognostic factors; however, it has been described that a reduction in the overall global quality of life score, mainly by physical function, increased pain, and dysphagia, are associated with mortality, and having high social well-being and global quality of life scores are associated with a lower risk of death. Objective: This study will measure association between Health-Related Quality of Life levels and mortality and progression free survival in advanced non-small cell lung cancer patients Patients and methods: This study will include patients with lung cancer histopathological confirmed including bronchus or trachea. Methodologically, the study has two components: One related to the exposure variable (HRQL), which involves a scale validation study, and other related to the measurement of the association between HRQoL and survival outcomes, which involves a prospective cohort analytical observational study. This last component will be carried out specifically with a sample of patients with non-small cell lung cancer (NSCLC). Results and impact: The project contribute to the implementation of tools adapted and validated in the Colombian context to assess the quality of life in patients with lung cancer. Additionally, knowing the relationship between quality of life and traditional oncological outcomes will provide tools to give patients with comprehensive treatment, and to have a prognosis of the disease that incorporates psychosocial aspects

Conditions

Lung Cancers; Lung Cancer, Non-Small Cell

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) is the average amount of time a patient survives after being diagnosed with or starting treatment for a disease

  36 months

Secondary Outcomes (1)

• Disease-Free Survival (DFS)

  36 months

Eligibility Criteria

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

Study Population

Advanced lung cancer

You may qualify if:

• Have a confirmed histologic diagnosis of non-small cell lung cancer
• Advanced stage (III to IV)
• years older
• Voluntary acceptance of participation

You may not qualify if:

• Present cognitive or sensory deficits that make it difficult to process the instruments used in the research
• Metachronous tumor

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead
• Hospital Universitario San Ignacio: collaborator
• Hospital Pablo Tobón Uribe: collaborator
• Hospital Alma Mater de Antioquia: collaborator

Study Sites (1)

Instituto Nacional de Cancerologia

Bogota, Cundinamarca, 111511, Colombia

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose A Carreno, Md

  Instituto Nacional de Cancerologia, Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: January 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)