- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248832
Smokers' Quitline for Asian Language Speakers
February 11, 2020 updated by: Shu-Hong Zhu, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2277
Phase
- 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
-
-
California
-
San Diego, California, United States, 92093
- University of California San Diego
-
-
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
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who are continuously abstinent from cigarettes
Time Frame: 7-months post enrollment
|
Continuous abstinence from cigarettes
|
7-months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who are continuously abstinent from cigarettes
Time Frame: 4-months post enrollment
|
Continuous abstinence from cigarettes
|
4-months post enrollment
|
Rate of serious quit attempts
Time Frame: 4-months post enrollment
|
Quit Attempts
|
4-months post enrollment
|
30-day point prevalence
Time Frame: 4-months post enrollment
|
30-day point prevalence
|
4-months post enrollment
|
30-day point prevalence
Time Frame: 7-months post enrollment
|
30-day point prevalence
|
7-months post enrollment
|
Rate of serious quit attempts
Time Frame: 7-months post enrollment
|
Quit Attempts
|
7-months post enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
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
August 1, 2004
Primary Completion (ACTUAL)
April 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
November 24, 2010
First Submitted That Met QC Criteria
November 24, 2010
First Posted (ESTIMATE)
November 25, 2010
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5R01CA104573-5
- R01CA104573 (NIH)
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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