Smoking CessationNCT01248832
Smokers' Quitline for Asian Language Speakers
A study testing Telephone Counseling and Self-Help Materials in people with Smoking Cessation, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Telephone Counseling and Self-Help Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,277 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old,
- daily smoker,
- ready to quit within one month,
- first time caller,
- valid phone number,
- valid address,
Show all 9Show fewer
- California (CA) resident,
- gave consent to participate in study and evaluation,
- called the Chinese, Korean or Vietnamese line
Who cannot join
- used other form of tobacco,
- major medical or psychiatric complication (e.g. lung cancer, major depressive disorder, anti-psychotic medicine, recent stroke, impending surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92093
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Telephone Counseling, Self-Help Materials
- Keywords
- tobacco cessation, smoking cessation, telephone, self-help, smoking abstinence, tobacco use disorder, disparity
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselingBehavioural
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 MaterialsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Counseling | Experimental | Telephone Counseling Receives: Behavioral: Telephone Counseling; Behavioral: Self-Help Materials |
| Self-help Materials | Active comparator | Self-help Materials Receives: Behavioral: Self-Help Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are continuously abstinent from cigarettes
Continuous abstinence from cigarettes
Measured: 7-months post enrollment
Secondary outcomes (5)
Number of participants who are continuously abstinent from cigarettes
Continuous abstinence from cigarettes
Measured: 4-months post enrollment
Rate of serious quit attempts
Quit Attempts
Measured: 4-months post enrollment
30-day point prevalence
30-day point prevalence
Measured: 4-months post enrollment
30-day point prevalence
30-day point prevalence
Measured: 7-months post enrollment
Rate of serious quit attempts
Quit Attempts
Measured: 7-months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startAug 2004
- Primary completionApr 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shu-Hong Zhu, University of California, San Diego
- Investigators
- Shu-Hong Zhu, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248832
- Sponsor's protocol ID
- 5R01CA104573-5
- Other IDs
- R01CA104573
- Status last verified
- Feb 2020
- First submitted
- 24 Nov 2010
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20299658
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smokers' Quitline for Asian Language Speakers
- ClinicalTrials.gov ID
- NCT01248832
- Acronym / sponsor ID
- 5R01CA104573-5
- Conditions
- Smoking Cessation
- Keywords
- tobacco cessation, smoking cessation, telephone, self-help, smoking abstinence, tobacco use disorder, disparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,277 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Counseling | Experimental | Behavioral: Telephone Counseling, Behavioral: Self-Help MaterialsTelephone Counseling |
| Self-help Materials | Active comparator | Behavioral: Self-Help MaterialsSelf-help Materials |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-75 years old,
- daily smoker,
- ready to quit within one month,
- first time caller,
- valid phone number,
Key exclusion criteria (2 listed)
- used other form of tobacco,
- major medical or psychiatric complication (e.g. lung cancer, major depressive disorder, anti-psychotic medicine, recent stroke, impending surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone CounselingCounseling 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. | Behavioural | Telephone Counseling |
| Self-Help MaterialsAll 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. | Behavioural | Self-help Materials, Telephone Counseling |
Primary outcome
Number of participants who are continuously abstinent from cigarettes
Time frame: 7-months post enrollment
Continuous abstinence from cigarettes
5 secondary outcomes
Number of participants who are continuously abstinent from cigarettes
Time frame: 4-months post enrollment
Rate of serious quit attempts
Time frame: 4-months post enrollment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 20299658Zhu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Hong Zhu, Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Counseling and Self-Help Materials in people with Smoking Cessation, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who are continuously abstinent from cigarettes (time frame: 7-months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.