Nicotine Dependence, Smoking
Conditions
Keywords
Smoking, Tobacco, Message Framing
Brief 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 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.
Interventions
BEHAVIORALGain-Framed counseling & Gain-framed materials
Novel messages for quitting smoking
BEHAVIORALStandard care counseling + standard materials
Standard messages for quitting smoking
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18+ years) * New York State residents * English-speaking * Current smokers who utilize Quitline services seeking quitting assistance for themselves
Exclusion criteria
* Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempt | 2 week follow up | Percentage of those that self reported attempting to quit smoking at the 2 week follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Abstinence | 2 week follow up | The number of survey respondents that had abstained from smoking at the 2 week follow up. |
| 7 Day Abstinence | 3 month follow up | The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Counseling Standard care counseling + standard care print information | 1,222 |
| Gain-Framed Counseling Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail. | 810 |
| Total | 2,032 |
Baseline characteristics
| Characteristic | Standard Care Counseling | Gain-Framed Counseling | Total |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 13.9 | 47.2 years STANDARD_DEVIATION 13.4 | 46.5 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 675 Participants | 478 Participants | 1153 Participants |
| Sex: Female, Male Male | 547 Participants | 332 Participants | 879 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,222 | 0 / 810 |
| serious Total, serious adverse events | 0 / 1,222 | 0 / 810 |
Outcome results
Primary
Quit Attempt
Percentage of those that self reported attempting to quit smoking at the 2 week follow up.
Time frame: 2 week follow up
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care Counseling | Quit Attempt | 101 participants |
| Gain-Framed Counseling | Quit Attempt | 132 participants |
Secondary
24 Hour Abstinence
The number of survey respondents that had abstained from smoking at the 2 week follow up.
Time frame: 2 week follow up
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care Counseling | 24 Hour Abstinence | 76 participants |
| Gain-Framed Counseling | 24 Hour Abstinence | 99 participants |
Secondary
7 Day Abstinence
The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.
Time frame: 3 month follow up
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care Counseling | 7 Day Abstinence | 202 participants |
| Gain-Framed Counseling | 7 Day Abstinence | 148 participants |