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
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Behavioral: Telephone Counseling
Behavioral: Self-Help Materials
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smokers' Quitline for Asian Language Speakers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2277
Study Start Date: August 2004
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone Counseling 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.
Active Comparator: Self-help Materials 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01248832

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
  More Information

Publications:
Responsible Party: Shu-Hong Zhu, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01248832     History of Changes
Other Study ID Numbers: 5R01CA104573-5, R01CA104573
Study First Received: November 24, 2010
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
tobacco cessation
smoking cessation
telephone
self-help
smoking abstinence
tobacco use disorder
disparity

ClinicalTrials.gov processed this record on October 23, 2014