Helping Poor Smokers Quit

Smoking Cessation Clinical Trial

Official title:

Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194958
• Other study ID #: R01CA201429
• Secondary ID: R01CA201429
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

Description:

2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.

Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1944
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Missouri resident

• English speaking

• Not in crisis

• Smoke cigarettes every day of the week

• Planning to quit smoking in the next 30 days

• Comfortable receiving calls from smoking expert and project team

• Willing to provide phone numbers to be reached

Exclusion Criteria:

• Pregnant or planning to become pregnant in the next 3 months

• Currently breastfeeding

• Insurance through employer

• Currently enrolled in smoking quitline

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Dependence Tobacco Product
• Nicotine Dependence, Cigarettes
• Nicotine Use Disorder
• Smoking
• Smoking (Tobacco) Addiction
• Smoking Cessation
• Smoking, Cigarette
• Smoking, Pipe
• Smoking, Tobacco
• Tobacco Dependence
• Tobacco Smoking
• Tobacco Use
• Tobacco Use Cessation
• Tobacco Use Disorder
• Tobacco; Use, Rehabilitation

Intervention

Behavioral:
• Specialized Quitline
Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.
• Basic Needs Navigator
Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 166 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence 6-months	Report 7-day point prevalence abstinence measured at 6-months post --baseline	6 months post-baseline
Secondary	Abstinence 3-months	Report 7-day point prevalence abstinence measured at 3-months post-baseline	3 months post-baseline
Secondary	24hr Quit Attempt	Report quitting smoking for at least 24 hours during intervention	6 months post-baseline

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine