- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645941
Connecting Alaska Native People to Quit Smoking (CAN Quit)
Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native Smokers
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Cessation Program Completion
Time Frame: 6 month follow-up assessment
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Number of participants to self-report a quit attempts since enrollment
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christi A Patten, Ph.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17-009947
- R34DA046008 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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