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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06900283
Acronym
FACT-L_Pred
Enrollment
320
Registered
2025-03-28
Start date
2021-01-01
Completion date
2025-12-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Non-Small Cell, Lung Cancers

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

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.

Interventions

None listed

Sponsors

Hospital Universitario San Ignacio
CollaboratorOTHER
Hospital Pablo Tobón Uribe
CollaboratorOTHER
Hospital Alma Mater de Antioquia
CollaboratorUNKNOWN
Instituto Nacional de Cancerologia, Columbia
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival36 monthsOverall survival (OS) is the average amount of time a patient survives after being diagnosed with or starting treatment for a disease

Secondary

MeasureTime frameDescription
Disease-Free Survival (DFS)36 monthsDisease-free survival (DFS) is the time after treatment when a patient is free of cancer signs and symptoms

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026