Lung CancersFACT-L_PredNCT06900283
Quality of Life as a Predictor of OS and PFS in Patients With Lung Cancer
An observational study of Lung Cancers and Lung Cancer, Non-Small Cell, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancers, Lung Cancer, Non-Small Cell
- How many people
- 320 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced lung cancer
Who may be able to join
- Have a confirmed histologic diagnosis of non-small cell lung cancer
- Advanced stage (III to IV)
- 8 years older
- Voluntary acceptance of participation
Who cannot join
- Present cognitive or sensory deficits that make it difficult to process the instruments used in the research
- Metachronous tumor
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, 111511
About this study
Official title: 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
Read more
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
Read the 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.
- Conditions
- Lung Cancers, Lung Cancer, Non-Small Cell
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) is the average amount of time a patient survives after being diagnosed with or starting treatment for a disease
Measured: 36 months
Secondary outcomes (1)
Disease-Free Survival (DFS)
Disease-free survival (DFS) is the time after treatment when a patient is free of cancer signs and symptoms
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Collaborators
- Hospital Universitario San Ignacio, Hospital Pablo Tobón Uribe, Hospital Alma Mater de Antioquia
- Responsible party
- Sponsor
- Investigators
- Jose A Carreno, Md, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900283
- Sponsor's protocol ID
- C19010300492 - FACT-L
- Other IDs
- C19010300492
- Acronym
- FACT-L_Pred
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life as a Predictor of Mortality and Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06900283
- Acronym / sponsor ID
- FACT-L_Pred / C19010300492 - FACT-L
- Conditions
- Lung Cancers, Lung Cancer, Non-Small Cell
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Collaborators
- Hospital Universitario San Ignacio, Hospital Pablo Tobón Uribe, Hospital Alma Mater de Antioquia
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced lung cancer
Key inclusion criteria (4 listed)
- Have a confirmed histologic diagnosis of non-small cell lung cancer
- Advanced stage (III to IV)
- 8 years older
- Voluntary acceptance of participation
Key exclusion criteria (2 listed)
- Present cognitive or sensory deficits that make it difficult to process the instruments used in the research
- Metachronous tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Disease-Free Survival (DFS)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Carreno, Md principal investigator
Instituto Nacional de Cancerologia, Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancers and Lung Cancer, Non-Small Cell, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.