Smokers' Quitline for Asian Language Speakers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shu-Hong Zhu, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01248832
First received: November 24, 2010
Last updated: December 10, 2013
Last verified: December 2013

November 24, 2010
December 10, 2013
August 2004
April 2008   (final data collection date for primary outcome measure)
  • Continuous abstinence from cigarettes [ Time Frame: 4-months post enrollment ] [ Designated as safety issue: No ]
  • Continuous abstinence from cigarettes [ Time Frame: 7-months post enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01248832 on ClinicalTrials.gov Archive Site
  • Rate of serious quit attempts [ Time Frame: 4-months post enrollment ] [ Designated as safety issue: No ]
  • 30-day point prevalence [ Time Frame: 4-months post enrollment ] [ Designated as safety issue: No ]
  • 30-day point prevalence [ Time Frame: 7-months post enrollment ] [ Designated as safety issue: No ]
  • Rate of serious quit attempts [ Time Frame: 7-months post enrollment ] [ Designated as safety issue: No ]
  • Rate of serious quit attempts [ Time Frame: 4-months post enrollment ] [ Designated as safety issue: No ]
  • 30-day point prevalence [ Time Frame: 4-months post enrollment ]
  • 30-day point prevalence [ Time Frame: 7-months post enrollment ]
  • Rate of serious quit attempts [ Time Frame: 7-months post enrollment ]
Not Provided
Not Provided
 
Smokers' Quitline for Asian Language Speakers
Smokers' Quitline for Asian Language Speakers

The study tested the effects of telephone counseling for smokers from three Asian language speaking groups: Chinese, Korean, and Vietnamese. The specific aims were to: 1) test the efficacy of a culturally appropriate counseling protocol for smokers calling the California Smokers' Helpline on the Chinese, Korean and Vietnamese lines, 2) examine whether intervention effects varied by cognitive and behavioral predictors of cessation success, 4) examine whether family involvement plays a role in quitting success, and 5) assess differences in counseling effect across the three ethnic groups.

Asian Americans are among the least studied groups in smoking research, which has created a knowledge gap in understanding their behavior and in developing methods to help them quit. No efficacy data have been reported for telephone counseling of smokers who prefer to use Asian languages, although telephone intervention holds promise for these groups because of its convenience and its potential to reach large numbers of smokers. In this two-arm design subjects are stratified by language (Chinese, Korean, and Vietnamese) and randomized to telephone counseling (plus materials) or self-help materials only, which serves as the control. The study is significant in several ways. First, it provides timely information on a cessation approach for a traditionally under-served population (Asian language speakers). Second, effective telephone counseling can be widely applied because of the proliferation of quitlines with centralized services in recent years. Third, by targeting Asian language speakers this study addresses the issue of ethnic disparities, which has been identified by many (including the NCI Bypass Budget) as a research priority.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Telephone Counseling
    Telephone counseling is conducted in Mandarin, Cantonese, Korean, or Vietnamese by veteran counselors at the California Smokers' Helpline. The counseling protocol is similar to that used by the Helpline in previous efficacy studies for English and Spanish speakers. However, the counseling is modified to make it culturally appropriate for Asian language speakers by: capitalizing on first contact, proactively presenting the Helpline as a credible quit smoking program staffed by "experts" and avoiding the term "counseling" since it is associated with mental illness, and assuming a more authoritative role and directive counseling style, in keeping with subject expectations. Counseling is proactive so after the smoker calls in subsequent calls are made by the counselor, a process that reduces attrition. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
  • Behavioral: Self-Help Materials
    All subjects (both in the telephone counseling group and the materials-only group) receive self-help materials in teh appropriate language. Materials were created in-house, are written in the appropriate language, and cover the essentials of the quitting process such as motivation, physiological and emotional responses to quitting, nicotine in the body, quitting aids, quitting strategies (including those that might be culturally specific such as acupuncture or herbs), setting a quit date, planning, relapse prevention, differentiating between slips and relapse, long-term maintenance, and developing the nonsmoker self-image.
  • Experimental: Telephone Counseling
    Interventions:
    • Behavioral: Telephone Counseling
    • Behavioral: Self-Help Materials
  • Active Comparator: Self-help Materials
    Intervention: Behavioral: Self-Help Materials
Zhu SH, Wong S, Stevens C, Nakashima D, Gamst A. Use of a smokers' quitline by Asian language speakers: results from 15 years of operation in California. Am J Public Health. 2010 May;100(5):846-52. doi: 10.2105/AJPH.2009.168385. Epub 2010 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2277
November 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-75 years old,
  • daily smoker,
  • ready to quit within one month,
  • first time caller,
  • valid phone number,
  • valid address,
  • California (CA) resident,
  • gave consent to participate in study and evaluation,
  • called the Chinese, Korean or Vietnamese line

Exclusion Criteria:

  • used other form of tobacco,
  • major medical or psychiatric complication (e.g. lung cancer, major depressive disorder, anti-psychotic medicine, recent stroke, impending surgery)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248832
5R01CA104573-5, R01CA104573
No
Shu-Hong Zhu, University of California, San Diego
University of California, San Diego
National Cancer Institute (NCI)
Not Provided
University of California, San Diego
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP