Newly Diagnosed Lung CancerNCT03642041
Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
An observational study of Newly Diagnosed Lung Cancer and Smoking, Cigarette, run by National Defense Medical Center, Taiwan.
Trial summary
1. Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis. 2. Explore the related factors of the smoking change patterns. 3. The type of smoking trajectory impact on survival and quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Newly Diagnosed Lung Cancer, Smoking, Cigarette, Survival
- What is being tested?
- smoking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2014to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed lung cancer patients
Who may be able to join
- Over 20 years old
- Newly diagnosed lung cancer
- Conscious clear and able to communicate
- Agreed to participate the study
Who cannot join
- Consciously confused
- Cognitive or psychotic disorders
About this study
Official title: Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
- Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis.
- Explore the related factors of the smoking change patterns.
- The type of smoking trajectory impact on survival and quality of life.
Read the detailed description
This was a prospective longitudinal design study. The investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.
- Being tested
- smoking
- Keywords
- Smoking, Lung cancer, Survival, Quality of life
- Medical subject headings
- Cigarette Smoking, Smoking, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smokingBehavioural
smoking behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline Smoking Behavior at 1,2,3,4,5,6 Months
Self-reported smoking during the last 30 days was a dichotomous variable.
Measured: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Secondary outcomes (2)
Changes From Baseline Quality of Life at 1,2,3,4,5,6 Months
Functional Assessment of Cancer Therapy-Lung, Version 4 (FACT-L v. 4) was a 36-item ordinal scale, five-point scale from 0 (not at all) to 4 (very much). There were 5 domains: Physical, social/family, emotional, and functional well-being; lung cancer subscale (symptoms, cognitive function, regret of smoking). Subscale scores added to obtain total score, with higher scores indicating better quality of life.
Measured: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Proportion of participants with Overall Survival up to 2 years
survival
Measured: follow up to one or two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start24 May 2014
- Primary completion22 Jul 2017
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Lung CancerStudies 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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Chia Chen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642041
- Sponsor's protocol ID
- TWNA-1042011
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT03642041
- Acronym / sponsor ID
- TWNA-1042011
- Keywords
- Smoking, Lung cancer, Survival, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 24 May 2014 (actual)
- Primary completion
- 22 Jul 2017 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 22 Aug 2018 (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.
- Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis.
- Explore the related factors of the smoking change patterns.
- The type of smoking trajectory impact on survival and quality of life.
Detailed description
This was a prospective longitudinal design study. The investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed lung cancer patients
Key inclusion criteria (4 listed)
- Over 20 years old
- Newly diagnosed lung cancer
- Conscious clear and able to communicate
- Agreed to participate the study
Key exclusion criteria (2 listed)
- Consciously confused
- Cognitive or psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smokingsmoking behavior | Behavioural | – |
Primary outcome
Changes From Baseline Smoking Behavior at 1,2,3,4,5,6 Months
Time frame: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Self-reported smoking during the last 30 days was a dichotomous variable.
2 secondary outcomes
Changes From Baseline Quality of Life at 1,2,3,4,5,6 Months
Time frame: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Proportion of participants with Overall Survival up to 2 years
Time frame: follow up to one or two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Lung Cancer and Smoking, Cigarette, run by National Defense Medical Center, Taiwan.
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: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes From Baseline Smoking Behavior at 1,2,3,4,5,6 Months (time frame: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month). 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 22 Aug 2018.