Expert System and Family Assisted Interventions for Chinese Smokers

Smoking Cessation Clinical Trial

Official title:

Expert System and Family Assisted Interventions for Chinese Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714467
• Other study ID #: TURSG-03-102-01 PBP
• Secondary ID: ACS Grant: TURSG
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: May 26, 2013
• Start date: August 2004
• Est. completion date: December 2008

Study information

• Verified date: May 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this study, we choose to specifically recruit Chinese, the largest ethnic group of the Asian and Pacific Islander community,2 as an initial step to increase our understanding of the role of family or supportive others in the process of smoking cessation among Asian Americans. We propose the following specific aims for the study:

1. Examine the effectiveness of proactive recruitment of Chinese smokers into a smoking cessation treatment program through their family or friends.

2. Test the efficacy of a family assisted intervention using the stages of change approach in promoting smoking cessation in the context of an expert system intervention.

3. Explore the role of supportive and non-supportive behaviors in relation to both short-term and long-term smoking cessation outcomes in the presence of the expert system intervention.

Description:

Limited empirical data are available on effective intervention approaches targeting Chinese American smokers. The overall goal of this study is to increase our understanding of the role of family or social support in the facilitation of the process of smoking cessation among Chinese smokers. We propose the following specific aims for the study: 1) Examine the effectiveness of proactive recruitment of Chinese smokers into a smoking cessation treatment program through their family or friends; 2) Test the efficacy of a family assisted intervention using the stages of change approach in promoting smoking cessation in the context of an expert system intervention; 3) Explore the role of supportive and non-supportive behaviors in relation to both short-term and long-term smoking cessation outcomes in the presence of the expert system intervention. This study will develop a family-assisted intervention in the form of a self-help booklet based on the Transtheoretical Model of Change (TTM) that will aim at teaching the supporters how to use the stages of change framework to apply different strategies that best match with smokers' readiness to quit smoking. This study will conduct focus groups and a pilot study to pre-test the study intervention and study procedures. The main randomized trial will recruit a total of 800 supporters and 800 smokers who are ethnic Chinese residing in the State of California. Each supporter-smoker pair will be randomly assigned to either 1) the expert system intervention only or 2) the expert system plus family-assisted intervention condition after baseline assessment by mail. All smokers in either condition will receive the expert system intervention. Half of the supporters will receive family-assisted intervention materials. All participants will be assessed at baseline, 3, 6, 12, and 18 months by mail or telephone. It is hypothesized that the expert system plus family-assisted intervention condition will yield significantly higher abstinence rates and higher portions to report quit attempts at follow-ups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• self-identified ethnic Chinese

• men and women

• above age 18

• can read and speak Chinese or English

• reside in the State of California at baseline

• to participate as a supporter, the participant must have a targeted smoker who meet the smoker eligibility criteria who provides consent to participate in the study as a smoker participant

• to participate as a smoker, the participant must have smoked at least 100 cigarettes in lifetime and have smoked at least 5 cigarettes in the past 7 days, and have a supporter who provides consent to be a supporter participant

Exclusion Criteria:

• smoker participant currently engage in other smoking cessation programs or efforts

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Expert System Only
expert system intervention only to the smoker participants which includes a stage-based manual and a series of 3 individualized tailored feedback report at baseline, 3, and 6 months. The paired-supporters receive assessments only and no intervention.
• Family Assisted
The smoker participants received an expert system intervention (same intervention for those in the Expert system intervention) which includes a stage-based manual and a series of 3 individualized tailored feedback report at baseline, 3, and 6 months. The paired-supporters will receive a a self-help booklet based on the Transtheoretical Model of Change (TTM) that will aim at teaching the supporters how to use the stages of change framework to apply different strategies that best match with smokers' readiness to quit smoking.

Locations

Country	Name	City	State
United States	UCSF Langley Porter	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Luk JW, Tsoh JY. Moderation of gender on smoking and depression in Chinese Americans. Addict Behav. 2010 Nov;35(11):1040-3. doi: 10.1016/j.addbeh.2010.06.021. Epub 2010 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-report 7-day smoking abstinence		12 months, 18 months	No
Secondary	self-report of at least a 24-hour quit attempt		12 months, 18 months	No