Smoking CessationNCT03194958
Helping Poor Smokers Quit
A study testing Specialized Quitline and Basic Needs Navigator in people with Smoking Cessation and Smoking, Tobacco, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette
- What is being tested?
- Specialized Quitline and Basic Needs Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,944 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or planning to become pregnant in the next 3 months
- Currently breastfeeding
- Insurance through employer
- Currently enrolled in smoking quitline
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs
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.
Read the detailed 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.
- Conditions
- Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette, Smoking, Pipe, Smoking (Tobacco) Addiction, Smoking
- Being tested
- Specialized Quitline, Basic Needs Navigator
- Medical subject headings
- Smoking Cessation, Tobacco Smoking, Cigarette Smoking, Pipe Smoking, Smoking, Behavior, Addictive, Tobacco Use, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized QuitlineBehavioural
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 NavigatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Quitline | No intervention | Participants will receive standard Missouri quitline services |
| Specialized Quitline | Experimental | Participants will receive an enhanced version of the standard quitline services Receives: Behavioral: Specialized Quitline |
| Standard Quitline with Basic Needs Navigator | Experimental | Participants receive standard quitline services with navigator Receives: Behavioral: Basic Needs Navigator |
| Specialized Quitline with Basic Needs Navigator | Experimental | Participants receive enhanced quitline services with navigator Receives: Behavioral: Specialized Quitline; Behavioral: Basic Needs Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence 6-months
Report 7-day point prevalence abstinence measured at 6-months post --baseline
Measured: 6 months post-baseline
Secondary outcomes (2)
Abstinence 3-months
Report 7-day point prevalence abstinence measured at 3-months post-baseline
Measured: 3 months post-baseline
24hr Quit Attempt
Report quitting smoking for at least 24 hours during intervention
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start5 Jun 2017
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (169)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,944 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Matthew Kreuter, Washington University School of Medicine
- Investigators
- Matthew Kreuter, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194958
- Sponsor's protocol ID
- R01CA201429
- Other IDs
- R01CA201429
- Status last verified
- Dec 2023
- First submitted
- 19 Jun 2017
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyum S, Kreuter MW, McQueen A, Thompson T, Greer R. Getting help from 2-1-1: A statewide study of referral outcomes. J Soc Serv Res. 2016;42(3):402-411. doi: 10.1080/01488376.2015.1109576. Epub 2016 Jan 22.
PubMed 28260823Cappelletti ER, Kreuter MW, Boyum S, Thompson T. Basic needs, stress and the effects of tailored health communication in vulnerable populations. Health Educ Res. 2015 Aug;30(4):591-8. doi: 10.1093/her/cyv033.
PubMed 26187910Kreuter MW, McQueen A, Boyum S, Fu Q. Unmet basic needs and health intervention effectiveness in low-income populations. Prev Med. 2016 Oct;91:70-75. doi: 10.1016/j.ypmed.2016.08.006. Epub 2016 Aug 3.
PubMed 27496395Thompson T, Kreuter MW, Boyum S. Promoting Health by Addressing Basic Needs: Effect of Problem Resolution on Contacting Health Referrals. Health Educ Behav. 2016 Apr;43(2):201-7. doi: 10.1177/1090198115599396. Epub 2015 Aug 20.
PubMed 26293458Zanis DA, Hollm RE, Derr D, Ibrahim JK, Collins BN, Coviello D, Melochick JR. Comparing intervention strategies among rural, low SES, young adult tobacco users. Am J Health Behav. 2011 Mar-Apr;35(2):240-7. doi: 10.5993/ajhb.35.2.11.
PubMed 21204686Richter KP, Shireman TI, Ellerbeck EF, Cupertino AP, Catley D, Cox LS, Preacher KJ, Spaulding R, Mussulman LM, Nazir N, Hunt JJ, Lambart L. Comparative and cost effectiveness of telemedicine versus telephone counseling for smoking cessation. J Med Internet Res. 2015 May 8;17(5):e113. doi: 10.2196/jmir.3975.
PubMed 25956257Ferketich AK, Pennell M, Seiber EE, Wang L, Farietta T, Jin Y, Wewers ME. Provider-delivered tobacco dependence treatment to Medicaid smokers. Nicotine Tob Res. 2014 Jun;16(6):786-93. doi: 10.1093/ntr/ntt221. Epub 2014 Jan 28.
PubMed 24474305Bush T, Levine MD, Beebe LA, Cerutti B, Deprey M, McAfee T, Boeckman L, Zbikowski S. Addressing weight gain in smoking cessation treatment: a randomized controlled trial. Am J Health Promot. 2012 Nov-Dec;27(2):94-102. doi: 10.4278/ajhp.110603-QUAN-238.
PubMed 23113779Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.
PubMed 22992296Perry RJ, Keller PA, Fraser D, Fiore MC. Fax to quit: a model for delivery of tobacco cessation services to Wisconsin residents. WMJ. 2005 May;104(4):37-40, 44.
PubMed 16117232Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002850. doi: 10.1002/14651858.CD002850.pub2.
PubMed 16855992Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care. 2000 Oct;45(10):1200-62.
PubMed 11054899Stead LF, Buitrago D, Preciado N, Sanchez G, Hartmann-Boyce J, Lancaster T. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD000165. doi: 10.1002/14651858.CD000165.pub4.
PubMed 23728631Bryant J, Bonevski B, Paul C, McElduff P, Attia J. A systematic review and meta-analysis of the effectiveness of behavioural smoking cessation interventions in selected disadvantaged groups. Addiction. 2011 Sep;106(9):1568-85. doi: 10.1111/j.1360-0443.2011.03467.x. Epub 2011 Jul 22.
PubMed 21489007Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM. Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. Health Educ Res. 1996 Jun;11(2):243-57. doi: 10.1093/her/11.2.243.
PubMed 10163409
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs
- ClinicalTrials.gov ID
- NCT03194958
- Acronym / sponsor ID
- R01CA201429
- Conditions
- Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette, Smoking, Pipe, Smoking (Tobacco) Addiction, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,944 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Quitline | No intervention | –Participants will receive standard Missouri quitline services |
| Specialized Quitline | Experimental | Behavioral: Specialized QuitlineParticipants will receive an enhanced version of the standard quitline services |
| Standard Quitline with Basic Needs Navigator | Experimental | Behavioral: Basic Needs NavigatorParticipants receive standard quitline services with navigator |
| Specialized Quitline with Basic Needs Navigator | Experimental | Behavioral: Specialized Quitline, Behavioral: Basic Needs NavigatorParticipants receive enhanced quitline services with navigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older
- Missouri resident
- English speaking
- Not in crisis
- Smoke cigarettes every day of the week
Key exclusion criteria (4 listed)
- Pregnant or planning to become pregnant in the next 3 months
- Currently breastfeeding
- Insurance through employer
- Currently enrolled in smoking quitline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized QuitlineVery 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. | Behavioural | Specialized Quitline, Specialized Quitline with Basic Needs Navigator |
| Basic Needs NavigatorNavigators 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. | Behavioural | Specialized Quitline with Basic Needs Navigator, Standard Quitline with Basic Needs Navigator |
Primary outcome
Abstinence 6-months
Time frame: 6 months post-baseline
Report 7-day point prevalence abstinence measured at 6-months post --baseline
2 secondary outcomes
Abstinence 3-months
Time frame: 3 months post-baseline
24hr Quit Attempt
Time frame: 6 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28260823Boyum S, Kreuter MW, McQueen A, Thompson T, Greer R. Getting help from 2-1-1: A statewide study of referral outcomes. J Soc Serv Res. 2016;42(3):402-411. doi: 10.1080/01488376.2015.1109576. Epub 2016 Jan 22.
- Background: PubMed 26187910Cappelletti ER, Kreuter MW, Boyum S, Thompson T. Basic needs, stress and the effects of tailored health communication in vulnerable populations. Health Educ Res. 2015 Aug;30(4):591-8. doi: 10.1093/her/cyv033.
- Background: PubMed 27496395Kreuter MW, McQueen A, Boyum S, Fu Q. Unmet basic needs and health intervention effectiveness in low-income populations. Prev Med. 2016 Oct;91:70-75. doi: 10.1016/j.ypmed.2016.08.006. Epub 2016 Aug 3.
- Background: PubMed 26293458Thompson T, Kreuter MW, Boyum S. Promoting Health by Addressing Basic Needs: Effect of Problem Resolution on Contacting Health Referrals. Health Educ Behav. 2016 Apr;43(2):201-7. doi: 10.1177/1090198115599396. Epub 2015 Aug 20.
- Background: PubMed 21204686Zanis DA, Hollm RE, Derr D, Ibrahim JK, Collins BN, Coviello D, Melochick JR. Comparing intervention strategies among rural, low SES, young adult tobacco users. Am J Health Behav. 2011 Mar-Apr;35(2):240-7. doi: 10.5993/ajhb.35.2.11.
- Background: PubMed 25956257Richter KP, Shireman TI, Ellerbeck EF, Cupertino AP, Catley D, Cox LS, Preacher KJ, Spaulding R, Mussulman LM, Nazir N, Hunt JJ, Lambart L. Comparative and cost effectiveness of telemedicine versus telephone counseling for smoking cessation. J Med Internet Res. 2015 May 8;17(5):e113. doi: 10.2196/jmir.3975.
- Background: PubMed 24474305Ferketich AK, Pennell M, Seiber EE, Wang L, Farietta T, Jin Y, Wewers ME. Provider-delivered tobacco dependence treatment to Medicaid smokers. Nicotine Tob Res. 2014 Jun;16(6):786-93. doi: 10.1093/ntr/ntt221. Epub 2014 Jan 28.
- Background: PubMed 23113779Bush T, Levine MD, Beebe LA, Cerutti B, Deprey M, McAfee T, Boeckman L, Zbikowski S. Addressing weight gain in smoking cessation treatment: a randomized controlled trial. Am J Health Promot. 2012 Nov-Dec;27(2):94-102. doi: 10.4278/ajhp.110603-QUAN-238.
- Background: PubMed 22992296Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.
- Background: PubMed 16117232Perry RJ, Keller PA, Fraser D, Fiore MC. Fax to quit: a model for delivery of tobacco cessation services to Wisconsin residents. WMJ. 2005 May;104(4):37-40, 44.
- Background: PubMed 16855992Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002850. doi: 10.1002/14651858.CD002850.pub2.
- Background: PubMed 11054899Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care. 2000 Oct;45(10):1200-62.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Kreuter, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Quitline and Basic Needs Navigator in people with Smoking Cessation and Smoking, Tobacco, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence 6-months (time frame: 6 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194958, which also lists 169 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.