SmokingPhase 1/2NCT00589277
Message Framing for Telephone Quitline Callers
A Phase 1/2 study testing Gain-Framed counseling & Gain-framed materials in people with Smoking and Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Nicotine Dependence
- What is being tested?
- Gain-Framed counseling & Gain-framed materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,032 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2009
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18+ years)
- New York State residents
- English-speaking
- Current smokers who utilize Quitline services seeking quitting assistance for themselves
Who cannot join
- Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers
The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.
Read the detailed description
This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions.
Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a "quit date" within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered.
Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.
- Conditions
- Smoking, Nicotine Dependence
- Being tested
- Gain-Framed counseling & Gain-framed materials, Standard care counseling + standard materials
- Keywords
- Smoking, Tobacco, Message Framing
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gain-Framed counseling & Gain-framed materialsBehavioural
Novel messages for quitting smoking
Standard care counseling + standard materialsBehavioural
Standard messages for quitting smoking
| Study group | Role | What they receive |
|---|---|---|
| Gain-Framed counseling & Gain-framed materials | Experimental | Novel messages for quitting smoking Receives: Behavioral: Gain-Framed counseling & Gain-framed materials |
| Standard care counseling + standard materials | Placebo comparator | Standard care counseling + standard care print information Receives: Behavioral: Standard care counseling + standard materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Attempt
Percentage of those that self reported attempting to quit smoking at the 2 week follow up.
Measured: 2 week follow up
Secondary outcomes (2)
24 Hour Abstinence
The number of survey respondents that had abstained from smoking at the 2 week follow up.
Measured: 2 week follow up
7 Day Abstinence
The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Benjamin A Toll, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589277
- Sponsor's protocol ID
- 0705002661
- Other IDs
- R21CA127818
- Status last verified
- Aug 2021
- First submitted
- 3 Jan 2008
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Toll BA, Martino S, Latimer A, Salovey P, O'Malley S, Carlin-Menter S, Hopkins J, Wu R, Celestino P, Cummings KM. Randomized trial: Quitline specialist training in gain-framed vs standard-care messages for smoking cessation. J Natl Cancer Inst. 2010 Jan 20;102(2):96-106. doi: 10.1093/jnci/djp468. Epub 2010 Jan 7.
PubMed 20056957
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers
- ClinicalTrials.gov ID
- NCT00589277
- Acronym / sponsor ID
- 0705002661
- Conditions
- Smoking, Nicotine Dependence
- Keywords
- Smoking, Tobacco, Message Framing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,032 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Posted 5 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.
Detailed description
This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions.
Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a "quit date" within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered.
Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gain-Framed counseling & Gain-framed materials | Experimental | Behavioral: Gain-Framed counseling & Gain-framed materialsNovel messages for quitting smoking |
| Standard care counseling + standard materials | Placebo comparator | Behavioral: Standard care counseling + standard materialsStandard care counseling + standard care print information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18+ years)
- New York State residents
- English-speaking
- Current smokers who utilize Quitline services seeking quitting assistance for themselves
Key exclusion criteria (1 listed)
- Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county
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 |
|---|---|---|
| Gain-Framed counseling & Gain-framed materialsNovel messages for quitting smoking | Behavioural | Gain-Framed counseling & Gain-framed materials |
| Standard care counseling + standard materialsStandard messages for quitting smoking | Behavioural | Standard care counseling + standard materials |
Primary outcome
Quit Attempt
Time frame: 2 week follow up
Percentage of those that self reported attempting to quit smoking at the 2 week follow up.
2 secondary outcomes
24 Hour Abstinence
Time frame: 2 week follow up
7 Day Abstinence
Time frame: 3 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20056957Toll BA, Martino S, Latimer A, Salovey P, O'Malley S, Carlin-Menter S, Hopkins J, Wu R, Celestino P, Cummings KM. Randomized trial: Quitline specialist training in gain-framed vs standard-care messages for smoking cessation. J Natl Cancer Inst. 2010 Jan 20;102(2):96-106. doi: 10.1093/jnci/djp468. Epub 2010 Jan 7.
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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.
Benjamin A Toll, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gain-Framed counseling & Gain-framed materials in people with Smoking and Nicotine Dependence, run by Yale University 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 4 inclusion and 1 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 Aug 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2013). 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?
Quit Attempt (time frame: 2 week follow up). 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 NCT00589277, which also lists 1 linked publication.
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 Aug 2021.