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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deep cultural arm | Experimental | deep cultural therapy |
|
| standard arm | Active Comparator | brief cessation counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard | Behavioral | 10 minute brief cessation counseling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month Abstinence | The number of participants who had maintained smoking abstinence for the past 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Verification of Self-reported Abstinence | The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml). | 12-month follow-ups |
Inclusion Criteria:
Korean-speaking Koreans who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun S Kim, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Massachusetts Boston | Boston | Massachusetts | 02125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21785963 | Result | 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. | |
| 24878686 | Result | 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. |
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Upon request, the data will be sent.
October 2009-September 2016
Researchers at non-profit academic institutions
232 people were screened and 123 were excluded before randomization.
2010-2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Cultural | This arm received eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT nicotine patch: 8-week nicotine patch therapy |
| FG001 | Standard | This arm received eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture. nicotine patch: 8-week nicotine patch therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Smokers of Korean ethnicity residing in the United States
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Cultural | eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT nicotine patch: 8-week nicotine patch therapy |
| BG001 | Standard |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 12-month Abstinence | The number of participants who had maintained smoking abstinence for the past 12 months | Korean Americans | Posted | Count of Participants | Participants | 12 months |
|
1 year
There was no case of participants at risk for other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cultural Tailoring | The group who received a deep Korean-culture tailored smoking cessation intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin reaction | Skin and subcutaneous tissue disorders | nicotine patches | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sun S Kim | University of Massachusetts Medical School | 201-388-2656 | sun.kim@umb.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| Deep Cultural |
| Behavioral |
Deep culturally tailored cognitive behavioral therapy |
|
| 6-month follow-up |
| 28747857 | Derived | 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. |
This arm receives eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture.
nicotine patch: 8-week nicotine patch therapy
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | age at the time of study enrollment | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | 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. | Korean Americans | Posted | Mean | Full Range | score on a scale | 6-month follow-up |
|
|
|
|
| Other Pre-specified | Biochemical Verification of Self-reported Abstinence | The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml). | Korean Americans who had smoked at least 10 cigarettes a day for the past 6 months before study enrollment. | Posted | Count of Participants | Participants | 12-month follow-ups |
|
|
|
| 3 |
| 55 |
| 0 |
| 55 |
| EG001 | Brief Cessation Counseling | The group who received a standard non-culture tailored smoking cessation intervention. | 2 | 54 | 0 | 54 |
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| D001519 | Behavior |