Expert System and Family Assisted Interventions for Chinese Smokers

May 26, 2013 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Langley Porter

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Expert system (stage-based manual and 3 individualized tailored feedback reports) only for smokers, paired-supporters (family or friend participant) do not receive any study 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.
Experimental: 2
Expert system (stage-based manual and 3 individualized tailored feedback report) to all the smoker participants; a family assisted intervention in a form of a self-help booklet that discusses specific strategies to work with smokers at each stage of change to the paired-supporters
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
self-report 7-day smoking abstinence
Time Frame: 12 months, 18 months
12 months, 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
self-report of at least a 24-hour quit attempt
Time Frame: 12 months, 18 months
12 months, 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

American Cancer Society, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 26, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TURSG-03-102-01 PBP
  • ACS Grant: TURSG-03-102-01 PBP
  • H10315-21203-07

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.

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