Expert System and Family Assisted Interventions for Chinese Smokers

This study has been completed.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00714467
First received: July 9, 2008
Last updated: May 26, 2013
Last verified: May 2013
  Purpose

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.

Condition Intervention
Smoking Cessation
Behavioral: Expert System Only
Behavioral: Family Assisted

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Expert System and Family Assisted Interventions for Chinese Smokers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • self-report 7-day smoking abstinence [ Time Frame: 12 months, 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-report of at least a 24-hour quit attempt [ Time Frame: 12 months, 18 months ] [ Designated as safety issue: No ]

Enrollment: 1280
Study Start Date: August 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714467

Locations
United States, California
UCSF Langley Porter
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
American Cancer Society, Inc.
Investigators
Principal Investigator: Janice Tsoh, PhD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00714467     History of Changes
Other Study ID Numbers: TURSG-03-102-01 PBP, ACS Grant: TURSG-03-102-01 PBP, H10315-21203-07
Study First Received: July 9, 2008
Last Updated: May 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
smoking cessation
Asian
Chinese American
family support
social support
stage-based intervention

ClinicalTrials.gov processed this record on September 18, 2014