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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
self-report 7-day smoking abstinence
Time Frame: 12 months, 18 months
12 months, 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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