NCT01248832

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

November 24, 2010

Last Update Submit

February 11, 2020

Conditions

Keywords

tobacco cessationsmoking cessationtelephoneself-helpsmoking abstinencetobacco use disorderdisparity

Outcome Measures

Primary Outcomes (1)

  • Number of participants who are continuously abstinent from cigarettes

    Continuous abstinence from cigarettes

    7-months post enrollment

Secondary Outcomes (5)

  • Number of participants who are continuously abstinent from cigarettes

    4-months post enrollment

  • Rate of serious quit attempts

    4-months post enrollment

  • 30-day point prevalence

    4-months post enrollment

  • 30-day point prevalence

    7-months post enrollment

  • Rate of serious quit attempts

    7-months post enrollment

Study Arms (2)

Telephone Counseling

EXPERIMENTAL

Telephone Counseling

Behavioral: Telephone CounselingBehavioral: Self-Help Materials

Self-help Materials

ACTIVE COMPARATOR

Self-help Materials

Behavioral: Self-Help Materials

Interventions

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.

Telephone Counseling

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.

Self-help MaterialsTelephone Counseling

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • used other form of tobacco,
  • major medical or psychiatric complication (e.g. lung cancer, major depressive disorder, anti-psychotic medicine, recent stroke, impending surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

Related 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.

    PMID: 20299658BACKGROUND

MeSH Terms

Conditions

Smoking CessationTobacco Use CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Shu-Hong Zhu, Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

August 1, 2004

Primary Completion

April 1, 2008

Study Completion

November 1, 2008

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations