Connecting Alaska Native People to Quit Smoking

NCT03645941 | Completed Results

• 2 other identifiers: 17-009947R34DA046008
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Smoking Cessation; Smoking, Cigarette; Smoking, Tobacco; Smoking

Keywords

Social Media; Alaska Native

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Self-reported 7-day Point Prevalence Smoking Abstinence

  6 months

• Self-reported Use of Evidence-based Cessation Treatments

  6 months

• Quit Attempts

  6 months

Study Arms (2)

Quitline/Treatment Referral

NO INTERVENTION

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)

Facebook+Quitline/Treatment Referral

EXPERIMENTAL

* 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

Interventions

Facebook Group BEHAVIORAL

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.

Facebook+Quitline/Treatment Referral

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Patten CA, Koller KR, Sinicrope PS, Prochaska JJ, Young C, Resnicow K, Decker PA, Hughes CA, Merritt ZT, McConnell CR, Huang M, Thomas TK. Facebook Intervention to Connect Alaska Native People With Resources and Support to Quit Smoking: CAN Quit Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Mar 22;25(4):803-813. doi: 10.1093/ntr/ntac221.

  PMID: 36130170 DERIVED

• Merculieff ZT, Koller KR, Sinicrope PS, Hughes CA, Bock MJ, Decker PA, Resnicow K, Flanagan CA, Meade CD, McConnell CR, Prochaska JJ, Thomas TK, Patten CA. Developing a Social Media Intervention to Connect Alaska Native People Who Smoke with Resources and Support to Quit Smoking: The Connecting Alaska Native Quit Study. Nicotine Tob Res. 2021 May 24;23(6):1002-1009. doi: 10.1093/ntr/ntaa253.

  PMID: 33674856 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Smoking Cessation; Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Results Point of Contact

• Title: Christi A. Patten, MD
• Organization: Mayo Clinic

patten.Christi@mayo.edu

507-266-2554

Study Officials

• Christi A Patten, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 24, 2018
• Study Start: December 13, 2019
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)