Smoking Reduction and Cessation Interventions for Chinese - Full Text View

Purpose

This study aims at developing and testing a stage-based scheduled smoking intervention that targets to encourage smokers to reduce smoking and to facilitate smoking abstinence. We hypothesize that smokers who receive the staged-based scheduled smoking intervention will be more likely to report smoking abstinence, quit attempts, and smoking reduction at 12 months.

Condition	Intervention
Smoking Cessation	Behavioral: Expert System Only Behavioral: Enhanced Expert System

MedlinePlus related topics:

Smoking Smoking Cessation

ChemIDplus related topics:

Nicotine polacrilex Nicotine tartrate BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Official Title:	A Stage-Based Scheduled Smoking Intervention for Chinese

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

self-report 7-day smoking abstinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

self-report a 24-hour quit attempt [ Time Frame: 12 months ] [ Designated as safety issue: No ]
50% or more reduction in smoking from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Expert system only, which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months.	Behavioral: Expert System Only Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months
2: Experimental The intervention consists of 3 components: Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months scheduled smoking intervention, which includes a tailored-made 3-week smoking reduction schedule and a stage-matched tip guide to explain why and how to use the smoking reduction intervention telephone check-in calls to provide brief counseling and technical support to motivate participants to use the intervention materials a 2-week supply of nicotine gum or lozenge per participants' choice to use during smoking reduction	Behavioral: Enhanced Expert System The intervention consists of 3 components: Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months scheduled smoking intervention, which includes a tailored-made 3-week smoking reduction schedule and a stage-matched tip guide to explain why and how to use the smoking reduction intervention telephone check-in calls to provide brief counseling and technical support to motivate participants to use the intervention materials a 2-week supply of nicotine gum or lozenge per participants' choice to use during smoking reduction

Detailed Description:

The objective of the study is to document and systematically investigate the use of smoking reduction and cessation strategies targeting Chinese American smokers at various level of readiness to quit smoking.

Using a randomized controlled study design, the experimental intervention will be compared to a control group that will receive the expert system intervention only at 3-, 6- and 12-month follow-up. The primary aim is to test the following hypotheses:

Participants receiving the experimental intervention will be more likely to achieve at least a 50% reduction from baseline at 3-month (end of treatment), 6- and 12-month follow-up than participants in the control condition.
Participants receiving the experimental intervention will be more likely to report a 24- hour quit attempt at 3-, 6- and 12-month follow-up.
Participants receiving the experimental intervention will be report a longer length of abstinence in their quit attempts at 3-, 6- and 12-month follow-up.
The experimental condition will yield a higher rate of smoking abstinence at 3-, 6- and 12-month follow-up.

The secondary aim is to examine the feasibility of the proposed intervention which will be assessed by recruitment efficiency, refusal rates, adherence, usage, safety data, and perceived helpfulness of the intervention components. In addition, analyses will be pursued to explore both short- and long-term maintenance of smoking reduction achieved, the association between smoking reduction and changes in self-efficacy of resisting from smoking, stage movements (changes in readiness for quitting), and the use of coping strategies for smoking at follow-ups. The study will provide important empirical data for developing effective smoking cessation strategies that are culturally and linguistically appropriate for the Chinese American population.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Self-identified ethnic Chinese men and women
18 years or older
report smoking cigarettes daily with at least 5 cigarettes per day in the last 7 days
reside in California
be able to read written English or Chinese

Exclusion Criteria:

Currently engaging in assisted smoking cessation efforts
Have health conditions that have contraindications of using nicotine replacement treatment (NRT) such as pregnancy, within 6 months post MI, severe or unstable angina

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714532

Contacts


Contact: Janice Tsoh, PhD	415-502-8438	jtsoh@lppi.ucsf.edu

Locations


United States, California
	UCSF Langley Porter	Recruiting
	San Francisco, California, United States, 94143
	Principal Investigator: Janice Tsoh, PhD

Sponsors and Collaborators

University of California, San Francisco

University of California Tobacco Related Disease Research Program

Investigators


Principal Investigator:	Janice Tsoh, PhD	University of California, San Francisco

More Information

smoking reduction and cessation interventions for Chinese smokers This link exits the ClinicalTrials.gov site

Responsible Party:	University of California San Francisco ( Janice Tsoh, PhD )
Study ID Numbers:	14RT-0160H, TRDRP grant: 14RT-0160H, H10315-27252-03B
First Received:	July 9, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00714532
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

smoking cessation

Asian American

Chinese American

smoking reduction

stage-based intervention

expert system

nicotine replacement

counseling

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Nicotine

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on September 19, 2008

Sponsors and Collaborators:	University of California, San Francisco University of California Tobacco Related Disease Research Program
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00714532