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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03642041
Other study ID # TWNA-1042011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 24, 2014
Est. completion date July 30, 2018

Study information

Verified date August 2018
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date July 30, 2018
Est. primary completion date July 22, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Intervention

Behavioral:
smoking
smoking behavior

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Defense Medical Center, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Secondary 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. baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Secondary Proportion of participants with Overall Survival up to 2 years survival follow up to one or two years
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