- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03642041
Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
August 20, 2018 updated by: Yang Chia Chen, National Defense Medical Center, Taiwan
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
406
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed lung cancer patients
Description
Inclusion Criteria:
- Over 20 years old
- Newly diagnosed lung cancer
- Conscious clear and able to communicate
- Agreed to participate the study
Exclusion Criteria:
- Consciously confused
- Cognitive or psychotic disorders
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 |
|---|---|---|
|
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.
|
baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
survival
|
follow up to one or two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 24, 2014
Primary Completion (Actual)
July 22, 2017
Study Completion (Actual)
July 30, 2018
Study Registration Dates
First Submitted
August 14, 2018
First Submitted That Met QC Criteria
August 20, 2018
First Posted (Actual)
August 22, 2018
Study Record Updates
Last Update Posted (Actual)
August 22, 2018
Last Update Submitted That Met QC Criteria
August 20, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TWNA-1042011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
Clinical Trials on smoking
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI); Ohio State University; Food and Drug Administration...CompletedTobacco-Related CarcinomaUnited States
-
Uppsala UniversityUnknown
-
The University of Hong KongNot yet recruiting
-
Wake Forest University Health SciencesNational Institute on Drug Abuse (NIDA)Completed
-
Istanbul UniversityRecruitingCornea | Anterior Eye Segment Measurements | Smoking ( Cigarette)Turkey (Türkiye)
-
Masonic Cancer Center, University of MinnesotaNational Institutes of Health (NIH)Completed
-
Philip Morris Products S.A.CompletedSmoking | Inflammation | Oxidative Stress | Smoking AbstinenceGermany, Japan, Czechia, Bulgaria, Poland, Greece
-
Meir Medical CenterUnknown
-
Masonic Cancer Center, University of MinnesotaUniversity of MinnesotaRecruiting
-
University of RijekaCroatian Science FoundationCompleted