Smoking Reduction and Cessation Interventions for Chinese

This study has been completed.
Sponsor:
Collaborator:
University of California
Information provided by (Responsible Party):
Janice Tsoh, Ph.D., University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00714532
First received: July 9, 2008
Last updated: July 9, 2013
Last verified: July 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Stage-Based Scheduled Smoking Intervention for Chinese

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 ] [ 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 ]

Enrollment: 298
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Experimental: 2

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:

  1. 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.
  2. Participants receiving the experimental intervention will be more likely to report a 24- hour quit attempt at 3-, 6- and 12-month follow-up.
  3. 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.
  4. 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
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: NCT00714532

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

No publications provided

Responsible Party: Janice Tsoh, Ph.D., Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00714532     History of Changes
Other Study ID Numbers: 14RT-0160H, TRDRP grant: 14RT-0160H, H10315-27252-03B
Study First Received: July 9, 2008
Last Updated: July 9, 2013
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

ClinicalTrials.gov processed this record on October 01, 2014