Quality of Life as a Predictor of OS and PFS in Patients With Lung Cancer (FACT-L_Pred)

March 31, 2025 updated by: Instituto Nacional de Cancerologia, Columbia

Quality of Life as a Predictor of Mortality and Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer

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

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The validation process of the scale includes the evaluation of internal consistency, content validity, sensitivity to change, test-retest reliability and the data will be analyzed according to the item response theory. In the cohort study, the association between HRQoL levels, mortality and progression-free survival will be measured in 250 patients with non-small cell lung cancer.

Analysis plan: Conventional methods of descriptive statistics will be applied in accordance with the characteristics of the variables. For validation procedures, exploratory and confirmatory factorial analysis techniques, estimation of correlation and internal consistency coefficients, and methods to compare means in repeated measures (ANOVA of repeated measures) will be used. In the cohort study, time-to-event models will be used (Cox proportional hazards models or parametric models, depending on the fulfillment of assumptions). Since the independent variable will have different times of measurement, time-to-event models will include methods that handle covariates that change over time.

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111511
        • Instituto Nacional de Cancerologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Advanced lung cancer

Description

Inclusion Criteria:

  1. Have a confirmed histologic diagnosis of non-small cell lung cancer
  2. Advanced stage (III to IV)
  3. 8 years older
  4. Voluntary acceptance of participation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: 36 months
Disease-free survival (DFS) is the time after treatment when a patient is free of cancer signs and symptoms
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia, Columbia

Collaborators

Hospital Universitario San Ignacio
Hospital Pablo Tobón Uribe
Hospital Alma Mater de Antioquia

Investigators

  • Principal Investigator: Jose A Carreno, Md, Instituto Nacional de Cancerologia, Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C19010300492 - FACT-L
  • C19010300492 (Other Identifier: Instituto Nacional de Cancerología)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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