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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01248832
Other study ID # 5R01CA104573-5
Secondary ID R01CA104573
Status Completed
Phase N/A
First received
Last updated
Start date August 2004
Est. completion date November 2008

Study information

Verified date February 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2277
Est. completion date November 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone Counseling
Counseling is conducted in Mandarin, Cantonese, Korean, or Vietnamese by counselors at the Helpline. The protocol used is similar to that proved efficacious. However, to make the counseling culturally appropriate for Asian language speakers, we: capitalizing on first contact, present the Helpline as a credible quit smoking program staffed by "experts", avoid the term "counseling" since it is associated with mental illness, and assume a more authoritative role and directive counseling style. Counseling is proactive (1st call is made by smoker, then subsequent calls are made by the counselor) to help reduce attrition. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) scheduled according to the probability of relapse.
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.

Locations

Country Name City State
United States University of California San Diego San Diego California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who are continuously abstinent from cigarettes Continuous abstinence from cigarettes 7-months post enrollment
Secondary Number of participants who are continuously abstinent from cigarettes Continuous abstinence from cigarettes 4-months post enrollment
Secondary Rate of serious quit attempts Quit Attempts 4-months post enrollment
Secondary 30-day point prevalence 30-day point prevalence 4-months post enrollment
Secondary 30-day point prevalence 30-day point prevalence 7-months post enrollment
Secondary Rate of serious quit attempts Quit Attempts 7-months post enrollment
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