Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients

• Sponsor: National Defense Medical Center, Taiwan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03642041
• Collaborator: (none)
• Enrollment: 406
• Actual Duration (Months): 50.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Newly Diagnosed Lung Cancer; Smoking, Cigarette; Survival; Quality of Life	Behavioral: smoking

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

• Study Type: Observational
• Actual Enrollment: 406 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
• Actual Study Start Date: May 24, 2014
• Actual Primary Completion Date: Jul 22, 2017
• Actual Study Completion Date: Jul 30, 2018

Outcome Measures

Primary Outcome Measures

1. Changes From Baseline Smoking Behavior at 1,2,3,4,5,6 Months [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.

Secondary Outcome Measures

1. Changes From Baseline Quality of Life at 1,2,3,4,5,6 Months [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.

2. Proportion of participants with Overall Survival up to 2 years [follow up to one or two years]

   survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Defense Medical Center, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Chia Chen, Principal Investigator, National Defense Medical Center, Taiwan
• ClinicalTrials.gov Identifier: NCT03642041
• Other Study ID Numbers: TWNA-1042011
• First Posted: Aug 22, 2018
• Last Update Posted: Aug 22, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yang Chia Chen, Principal Investigator, National Defense Medical Center, Taiwan: Smoking; Lung cancer; Survival; Quality of life
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Aug 22, 2018