Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2012-11-14
2013-08-31
Brief Summary
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Detailed Description
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Aim 1. Determine the impact of knowing personal genotyping results for nicotine dependence risk on the smoking cessation (primary) outcomes at weeks 2, 6, and 10.
The working hypotheses for the cessation-related behaviors are:
1. When compared to the control group, the experimental group will have greater: (1) smoking abstinence; (2) use of formal smoking cessation programs; (3) contact with health-care provider for cessation; (4) use of pharmacotherapy, and (5) use of self-management strategies for cessation.
2. There will be no difference in the number of quit attempts between the experimental and control groups.
The working hypotheses for the cessation-related cognitions are:
1. When compared to the control group, the experimental group will have higher self-efficacy for smoking cessation.
2. When compared to the control group, the experimental group will have higher abstainer and lower smoker self-schemas.
The secondary aims are:
Aim 2. Determine the impact of knowing personal genotyping results for nicotine dependence risk on the secondary genetic literacy (secondary) outcomes at weeks 2, 6, and 10.
The working hypotheses for the genetic literacy-related cognitions and emotions are:
1. When compared to the control group, the experimental group will have greater: (1) knowledge of genetic contributions to smoking, (2) mental representations indicating endorsement of genetic risk for nicotine dependence, (3) accurate perceptions of genetic risk for nicotine dependence, and (4) self-efficacy for use of genotyping results.
2. There will be no difference in psychological distress between the experimental and control groups.
Aim 3. Explore smokers' perceptions and experiences that contextualize participation in genetic education and genotyping for nicotine dependence risk. We will conduct focus groups with both the intervention and control group participants at weeks 2 and 6 after intervention group participants receive their genotyping results.
Aim 4. Determine the feasibility of an intervention that informs people of their personal genotype results for nicotine dependence risk for a larger clinical trial, including evaluation of enrollment (recruitment efficiency, attrition, problems and solutions), intervention fidelity (delivery, receipt, enactment), data collection, subject acceptability of the intervention, and estimation of effect sizes for sample size determination in future, larger clinical trials.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Receipt of Genetic Results
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receipt of Genetic Results
Participants will receive the results of genotyping for RS1051730
No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
Interventions
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Receipt of Genetic Results
Participants will receive the results of genotyping for RS1051730
No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
Eligibility Criteria
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Inclusion Criteria
* smoking\>= 10 cigarettes/day;
* intention to quit smoking at some time in the future;
* able to understand, speak, and write in English, and
* physically and mentally able to participate.
The investigators are excluding participants who do not understand, speak or write in English at this time because: (1) the consent document, the educational genetics presentation, and data collection forms are currently written in English only and (2)the resources to make the educational presentation and data collection documents culturally-specific for other cultures are not available. In making the study relevant for non-English speaking participants, it is not only a literal translation the presentation and documents into another language that is needed, but the ideas of health and heredity from the culture related to the language also need to be taken into account when presenting the study and the study materials in another language.
Exclusion Criteria
* diagnosis of cancer (other than basal or squamous cell skin cancer) or other life-threatening illness;
* pregnant, or
* currently enrolled in another smoking research study.
19 Years
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Julia F Houfek, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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References
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Other Identifiers
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0069-12-FB
Identifier Type: -
Identifier Source: org_study_id
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