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Connecting Alaska Native People to Quit Smoking

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03645941
Acronym
CAN Quit
Enrollment
61
Registered
2018-08-24
Start date
2019-12-13
Completion date
2021-03-26
Last updated
2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Social Media, Alaska Native

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.

Interventions

BEHAVIORALFacebook 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Smoking Cessation Program Completion6 month follow-up assessmentThe number of participants that completed the smoking cessation program and all activities per protocol
Biochemically Confirmed Abstinence From Smoking6 monthsNumber of participants to have biochemically verified smoking abstinence by saliva specimen with cotinine level \<15ng/ml

Secondary

MeasureTime frameDescription
Self-reported 7-day Point Prevalence Smoking Abstinence6 monthsNumber of participants to self-report smoking abstinence during the past seven days (not even a puff)
Self-reported Use of Evidence-based Cessation Treatments6 monthsNumber 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.
Quit Attempts6 monthsNumber of participants to self-report a quit attempts since enrollment

Countries

United States

Participant flow

Participants by arm

ArmCount
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)
30
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) 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.
31
Total61

Baseline characteristics

CharacteristicQuitline/Treatment ReferralTotalFacebook+Quitline/Treatment Referral
Age, Continuous39.5 years
STANDARD_DEVIATION 11
40.3 years
STANDARD_DEVIATION 11.9
41.2 years
STANDARD_DEVIATION 12.9
Race (NIH/OMB)
American Indian or Alaska Native
30 Participants61 Participants31 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
30 participants61 participants31 participants
Sex: Female, Male
Female
19 Participants38 Participants19 Participants
Sex: Female, Male
Male
11 Participants23 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 31
other
Total, other adverse events
0 / 300 / 31
serious
Total, serious adverse events
0 / 300 / 31

Outcome results

Primary

Biochemically Confirmed Abstinence From Smoking

Number of participants to have biochemically verified smoking abstinence by saliva specimen with cotinine level \<15ng/ml

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitline/Treatment ReferralBiochemically Confirmed Abstinence From Smoking2 Participants
Facebook+Quitline/Treatment ReferralBiochemically Confirmed Abstinence From Smoking2 Participants
Primary

Smoking Cessation Program Completion

The number of participants that completed the smoking cessation program and all activities per protocol

Time frame: 6 month follow-up assessment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitline/Treatment ReferralSmoking Cessation Program Completion16 Participants
Facebook+Quitline/Treatment ReferralSmoking Cessation Program Completion19 Participants
Secondary

Quit Attempts

Number of participants to self-report a quit attempts since enrollment

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitline/Treatment ReferralQuit Attempts11 Participants
Facebook+Quitline/Treatment ReferralQuit Attempts13 Participants
Secondary

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)

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitline/Treatment ReferralSelf-reported 7-day Point Prevalence Smoking Abstinence7 Participants
Facebook+Quitline/Treatment ReferralSelf-reported 7-day Point Prevalence Smoking Abstinence3 Participants
Secondary

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.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitline/Treatment ReferralSelf-reported Use of Evidence-based Cessation Treatments4 Participants
Facebook+Quitline/Treatment ReferralSelf-reported Use of Evidence-based Cessation Treatments8 Participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026