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Connecting Alaska Native People to Quit Smoking (CAN Quit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Tobacco Use Tobacco Smoking Tobacco Use Cessation Smoking Cessation Smoking, Cigarette Smoking, Tobacco Smoking Behavioral: Facebook Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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
Official Title: Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native Smokers
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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.




Primary Outcome Measures :
  1. Smoking cessation program completion [ Time Frame: 6 month follow-up assessment ]
    The number of participants that completed the smoking cessation program


Secondary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 6 month follow-up assessments ]
    7 day, biochemically-confirmed smoking abstinence rate

  2. Smoking Cessation Treatment Utilization [ Time Frame: 6 month study period ]
    Self-reported engagement in smoking cessation treatment or medications used

  3. Quit Attempts [ Time Frame: 6 month follow-up assessments ]
    Obtain self-reported quit attempts

  4. Tobacco Use [ Time Frame: 6 month follow-up assessments ]
    Obtain current use of smokeless tobacco (ST)/iqmik, e-cigarettes, and other tobacco/nicotine products



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645941


Contacts
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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

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Christine A Hughes, BS    507-538-7443    hughes.christine@mayo.edu   
Contact: Pamela S Sinicrope, DrPH    507-266-1238    sinicrope.pamela@mayo.edu   
Principal Investigator: Christi A Patten, PhD         
Sponsors and Collaborators
Mayo Clinic
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Christi A Patten, Ph.D. Mayo Clinic
Additional Information:
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Responsible Party: Christi Patten, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03645941    
Other Study ID Numbers: 17-009947
R34DA046008 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data elements and data transfer activities will be strictly compliant with HIPAA privacy regulatory requirements.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christi Patten, Mayo Clinic:
Social Media
Alaska Native