Connecting Alaska Native People to Quit Smoking

Study Overview
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Brief Summary
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The prevalence of smoking among US adults is highest among American Indians and Alaska Native (AI/AN) persons; however, there are a lack of tobacco cessation interventions developed specific to this disparity group. Social media holds promise as a scalable intervention strategy to promote engagement in treatment and cessation outcomes for Alaska Native (AN) people. Researchers plan to develop and pilot test a culturally relevant, Facebook delivered intervention to promote smoking treatment uptake and cessation among AN smokers. The Facebook content will include a digital storytelling approach adapted from the effective Centers for Disease Control (CDC) Tips from Former Smokers educational mass media campaign. The project builds on the researcher team's longstanding tobacco control research partnership with the AN community and was informed by their understanding of cultural factors that can both impede and encourage cessation in this population. If the pilot intervention is successful, researchers will have a blueprint to conduct a large randomized controlled trial. The researchers long-term objective is to develop interventions for AN tobacco users that will ultimately reduce their risk of tobacco-caused disease and mortality.

Detailed Description
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The Behavioral Health Research Program at Mayo Clinic will be coordinating the study (recruit, train, oversee, etc.), but the project will take place in Alaska. The study will be conducted at the Alaska Native Tribal Health Consortium (ANTHC) in Anchorage. All data collection and the intervention will be conducted by study staff at ANTHC and Mayo Clinic. For qualitative data collection, a semi-structured interviewer guide will be developed and the project coordinator in Alaska will conduct the interviews. Researchers will provide training for the project coordinator on-site in Anchorage including 4 hours of didactic instruction followed by 4 practice hours of mock interviews and a certified completion interview. All sessions will be audiotaped. These transcripts will be coded by the researchers to assess counselor adherence to the proscribed intervention, and feedback will be provided during weekly research team teleconferences. Mayo Clinic social media department will create the Facebook group page, develop the content library of moderator postings, and set up the software to capture participant use data. A random sample of 20% of moderator postings and responses to participant inquiries and discussions will be selected every week for the first four weeks and monthly thereafter. These transcripts will be coded by the researchers to assess moderator adherence to the proscribed intervention, and feedback will be provided during weekly research team teleconferences. A manual of study procedures will be developed for the project coordinator in Alaska (AK). A Mayo Clinic program coordinator and clinical trials coordinator, will travel with a Mayo Clinic Co-Investigator to Anchorage, AK, to train the project coordinator on the data collection and other study procedures. The same coordination, communication, and quality control procedures will be used that have been successfully utilized in previous work. For ongoing trials in Alaska, weekly conference calls are scheduled with study staff in AK and at Mayo Clinic to discuss progress and problem solve issues related to recruitment and data collection. Quality control of the data is also monitored on site through review of participant forms and procedures every 3 months. The biostatistician on this protocol will oversee the transfer of data forms, electronic data, and data storage. The Mayo Survey Research Center will electronically transfer all data to the biostatistician. The quality of the data (data checks) including missing data and presence and frequency of outliers will be monitored once per month by the biostatistician. For study recruitment, the project coordinator will track posting of ads through Facebook (FB) and in Alaska local newsletters and websites. All measures will be administered online using Qualtrics software, a data security service. An email link will be sent automatically by the Mayo Clinic Survey Research Center to complete the assessment. If a participant does not complete online assessments, the participant will be contacted through email or by phone by the project coordinator and prompted to complete the assessment. Data collected from survey responses will be handled and maintained by the Mayo Clinic Survey Research Center and a de-identified database of responses will be provided to the investigators. Interview forms and audio tapes will be labeled with subject ID numbers only; all personal identifiers will be removed before the data are sent to Mayo Clinic for analysis. At Mayo Clinic the audio tapes will be stored in a locked file drawer accessible only to the PI, Co-Investigator, and the project coordinator. These will be destroyed once the interviews are fully transcribed. A trained research assistant at Mayo Clinic will mail the saliva sample kit to the participant; and the saliva samples, labeled with a subject identifier (ID) number only, will be shipped directly back to Mayo Clinic for analysis of cotinine. Once the specimen sample is processed and results posted, the sample will be destroyed immediately. The study staff in Anchorage and Rochester will monitor any reports or observations of medical problems or severe depression or other psychiatric symptoms in participants. The Principal Investigator (PI) and a Co-Investigator from Stanford University, licensed clinical psychologists, will be consulted by telephone to consult with the study staff as needed.

Official Title
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Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native Smokers

Conditions
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Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco, Smoking

Intervention / Treatment
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* Behavioral: Facebook Group


Participation Criteria
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Eligibility Criteria
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Inclusion and Exclusion Criteria Participants must be: >19 years of age (legal smoking age), Alaska Native race/ethnicity, smoke at least 1 cigarette per day over the past 7 day period, if other tobacco use, cigarettes are the main tobacco product used, considering or willing to make a quit attempt, access to internet, have an existing Facebook account or willing to set up an account, and is not using pharmacotherapy or has not enrolled in a program to stop smoking for past 3 months. Each person is only eligible to participate in one part of the study.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Our approach follows the three-stage model of behavioral therapies development and the proposed aims correspond to the two sub-stages characterizing Stage I work. In Stage Ia formative work, we will develop the Facebook intervention. In Stage Ib, we will use rigorous design and methodology to evaluate the intervention's feasibility and potential efficacy. Stage Ib results will inform a future R01, Stage II, randomized efficacy trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Quitline/Treatment Referral<br>Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide) | |
| Experimental: Facebook+Quitline/Treatment Referral<br>Participants join a secret/private, culturally relevant Facebook group moderated by an AN tobacco research counselor for 3 months Once daily moderator postings for 30 days, repeated each month for 3 months; plus 3-4 daily check-ins/postings to respond to participant generated content and encourage sharing of personal stories/experiences relevant to all stages of the quitting process and treatment engagement Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide) | Behavioral: Facebook Group<br>* The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized within stratified blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); potential variables related to outcomes. Assessments will be conducted for both study groups at baseline and at 1, 3, and 6 month follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation Program Completion | The number of participants that completed the smoking cessation program and all activities per protocol | 6 month follow-up assessment | 
| Biochemically Confirmed Abstinence From Smoking | Number of participants to have biochemically verified smoking abstinence by saliva specimen with cotinine level <15ng/ml | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 7-day Point Prevalence Smoking Abstinence | Number of participants to self-report smoking abstinence during the past seven days (not even a puff) | 6 months | 
| Self-reported Use of Evidence-based Cessation Treatments | Number of participants to self-report use of evidence-based cessation treatments including Alaska's Tobacco Quitline, Tribal cessation programs, cessation assistance from a health care provider, nicotine replacement therapy, and other stop-smoking medications. | 6 months | 
| Quit Attempts | Number of participants to self-report a quit attempts since enrollment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Media, Alaska Native