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Connecting Alaska Native People to Quit Smoking (CAN Quit)

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ClinicalTrials.gov Identifier: NCT03645941
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE August 6, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE October 9, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Smoking cessation program completion [ Time Frame: 6 month follow-up assessment ]
The number of participants that completed the smoking cessation program
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
Intervention Completion [ Time Frame: 6 month follow-up assessment ]
The # of participants enrolled that completed the intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Smoking Abstinence [ Time Frame: 6 month follow-up assessments ]
    7 day, biochemically-confirmed smoking abstinence rate
  • Smoking Cessation Treatment Utilization [ Time Frame: 6 month study period ]
    Self-reported engagement in smoking cessation treatment or medications used
  • Quit Attempts [ Time Frame: 6 month follow-up assessments ]
    Obtain self-reported quit attempts
  • Tobacco Use [ Time Frame: 6 month follow-up assessments ]
    Obtain current use of smokeless tobacco (ST)/iqmik, e-cigarettes, and other tobacco/nicotine products
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connecting Alaska Native People to Quit Smoking
Official Title  ICMJE Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native Smokers
Brief Summary

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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Use
  • Tobacco Smoking
  • Tobacco Use Cessation
  • Smoking Cessation
  • Smoking, Cigarette
  • Smoking, Tobacco
  • Smoking
Intervention  ICMJE Behavioral: Facebook Group
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.
Study Arms  ICMJE
  • No Intervention: Quitline/Treatment Referral
    •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
    • 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)
    Intervention: Behavioral: Facebook Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion and Exclusion Criteria

Participants must be:

  1. >19 years of age (legal smoking age),
  2. Alaska Native race/ethnicity,
  3. smoke at least 1 cigarette per day over the past 7 day period,
  4. if other tobacco use, cigarettes are the main tobacco product used,
  5. considering or willing to make a quit attempt,
  6. access to internet,
  7. have an existing Facebook account or willing to set up an account, and
  8. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Christine A Hughes, B.S. 507-538-7443 hughes.christine@mayo.edu
Contact: Pamela S Sinicrope, Ph.D. 507-266-1238 sinicrope.pamela@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03645941
Other Study ID Numbers  ICMJE 17-009947
R34DA046008 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: All data elements and data transfer activities will be strictly compliant with HIPAA privacy regulatory requirements.
Responsible Party Christi Patten, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Christi A Patten, Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP