Tobacco Dependence Treatment for Asian Americans
Primary Purpose
Tobacco Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard
Deep Cultural
Sponsored by
About this trial
This is an interventional prevention trial for Tobacco Dependence focused on measuring smoking cessation, tobacco dependence treatment, cultural adaptation, Asian Americans
Eligibility Criteria
Inclusion Criteria:
Korean-speaking Koreans who:
- Are ages of 18 and older
- Have been smoking at least 10 or more cigarettes on average per day for the past 30 days; AND
- Are willing to quit smoking and receive NRT
Exclusion Criteria:
- Inability to speak and understand Korean or English
- Involvement in behavioral or other pharmacological smoking cessation programs
- History of serious cardiac diseases and/or presence of skin diseases (see Human Subjects); OR
- Pregnancy, lactation or plans to become pregnant in the next 12 months
Sites / Locations
- University Massachusetts Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
deep cultural arm
standard arm
Arm Description
deep cultural therapy
brief cessation counseling
Outcomes
Primary Outcome Measures
12-month Abstinence
The number of participants who had maintained smoking abstinence for the past 12 months
Secondary Outcome Measures
Perceived Family Norm Toward Quitting Smoking
Perceived family norm toward quitting smoking was assessed using the Perceived Family Norm Index consisting of two items assessing normative beliefs (i.e., "I believe that my family [my friends] wants me to quit smoking") and motivation to comply with the belief (i.e., "I am willing to comply with the belief"). Score for each item can range from -3 "strongly disagree" to +3 "strongly agree". The total score is the sum of the scores of the two items and can range from -6 to +6.
Full Information
NCT ID
NCT01091363
First Posted
March 21, 2010
Last Updated
February 20, 2019
Sponsor
University of Massachusetts, Boston
1. Study Identification
Unique Protocol Identification Number
NCT01091363
Brief Title
Tobacco Dependence Treatment for Asian Americans
Official Title
A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nicotine dependence is very common among Asian Americans; yet, research on understanding and treating nicotine dependence in this group is almost nonexistent. The proposed study is a first attempt to develop a smoking cessation program that is tailored to Korean-culture specific aspects. It is proposed that Korean Americans who receive a culturally tailored smoking cessation program will be more likely to have prolonged abstinence at 12-month follow-up than their counterparts who receive brief cessation counseling. Subjects in both arms receive nicotine patches for 8 weeks. Self-reported abstinence is validated with exhaled carbon monoxide and salivary cotinine tests.
Detailed Description
Korean men have been known for very high smoking rates and the highest cancer death smoking-attributable fraction. In contrast, Korean women reportedly smoke at low rates compared to the general U.S. population. However, recent population-based survey data indicate steady increases in smoking prevalence of Korean American women. Particularly, it has been found that they tend to initiate smoking as they acculturate into social norms of American women. Preliminary data of the applicant and others suggests interventions must be culturally adapted and a motivation-based and family-involved approach is most promising. The training plan will help the applicant develop an independent program of drug abuse research that focuses on better understanding and treating tobacco dependence among Asian Americans, including evaluating culturally competent and gender-specific interventions. The research plan will examine the impact of culture and gender on nicotine dependence and utilize National Institute on Drug Abuse behavioral therapy development methods. The proposed research plan has two-phases and evaluates tobacco dependence treatment with Korean Americans (N = 164, 50% women). Phase 1 is a no-control group study (Stage Ia) that is aimed at developing an intervention manual of Group-based Motivational Interviewing (GMI) intervention, therapists' adherence and competence scales, training program, and small feasibility intervention study with 20 Korean-American (offered separately for men and women). Phase 2 is a randomized controlled trial (Stage Ib) with 144 Korean Americans that is conducted to assess feasibility and relative effectiveness of the GMI behavioral intervention in conjunction with Nicotine Replacement Therapy (NRT) in comparison with a brief group medication management of NRT. Gender-interaction effects of psychosocial variables on treatment outcomes will be assessed, including acculturation and depression. This award will help prepare the applicant for an independent research career focusing on Asian Americans and Nicotine Dependence, including adapting and testing new interventions for different populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
smoking cessation, tobacco dependence treatment, cultural adaptation, Asian Americans
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
deep cultural arm
Arm Type
Experimental
Arm Description
deep cultural therapy
Arm Title
standard arm
Arm Type
Active Comparator
Arm Description
brief cessation counseling
Intervention Type
Behavioral
Intervention Name(s)
Standard
Intervention Description
10 minute brief cessation counseling
Intervention Type
Behavioral
Intervention Name(s)
Deep Cultural
Intervention Description
Deep culturally tailored cognitive behavioral therapy
Primary Outcome Measure Information:
Title
12-month Abstinence
Description
The number of participants who had maintained smoking abstinence for the past 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Perceived Family Norm Toward Quitting Smoking
Description
Perceived family norm toward quitting smoking was assessed using the Perceived Family Norm Index consisting of two items assessing normative beliefs (i.e., "I believe that my family [my friends] wants me to quit smoking") and motivation to comply with the belief (i.e., "I am willing to comply with the belief"). Score for each item can range from -3 "strongly disagree" to +3 "strongly agree". The total score is the sum of the scores of the two items and can range from -6 to +6.
Time Frame
6-month follow-up
Other Pre-specified Outcome Measures:
Title
Biochemical Verification of Self-reported Abstinence
Description
The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml).
Time Frame
12-month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Korean-speaking Koreans who:
Are ages of 18 and older
Have been smoking at least 10 or more cigarettes on average per day for the past 30 days; AND
Are willing to quit smoking and receive NRT
Exclusion Criteria:
Inability to speak and understand Korean or English
Involvement in behavioral or other pharmacological smoking cessation programs
History of serious cardiac diseases and/or presence of skin diseases (see Human Subjects); OR
Pregnancy, lactation or plans to become pregnant in the next 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun S Kim, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Massachusetts Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request, the data will be sent.
IPD Sharing Time Frame
October 2009-September 2016
IPD Sharing Access Criteria
Researchers at non-profit academic institutions
IPD Sharing URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4250475/pdf/nihms-600738.pdf
Citations:
PubMed Identifier
21785963
Citation
Kim SS, Kim SH, Ziedonis D. Tobacco dependence treatment for Korean Americans: preliminary findings. J Immigr Minor Health. 2012 Jun;14(3):395-404. doi: 10.1007/s10903-011-9507-0.
Results Reference
result
PubMed Identifier
24878686
Citation
Kim SS, Kim SH, Fang H, Kwon S, Shelley D, Ziedonis D. A Culturally Adapted Smoking Cessation Intervention for Korean Americans: A Mediating Effect of Perceived Family Norm Toward Quitting. J Immigr Minor Health. 2015 Aug;17(4):1120-9. doi: 10.1007/s10903-014-0045-4.
Results Reference
result
PubMed Identifier
28747857
Citation
Kim SS, Fang H, Bernstein K, Zhang Z, DiFranza J, Ziedonis D, Allison J. Acculturation, Depression, and Smoking Cessation: a trajectory pattern recognition approach. Tob Induc Dis. 2017 Jul 24;15:33. doi: 10.1186/s12971-017-0135-x. eCollection 2017.
Results Reference
derived
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Tobacco Dependence Treatment for Asian Americans
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