Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline(Quitline)

Study Overview
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Brief Summary
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The study primary purpose is smoking relapse prevention. This study is a collaboration between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt Cancer Center in Tampa, Florida, and those associated with the New York State Smokers' Quitline (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.

Detailed Description
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In this study, approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call. One-third will be randomized to a Usual Care (UC) condition, which will receive regular quitline services. One-third will be randomized to a Repeated Mailings (RM) condition, which will receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months. And one-third will be randomized to a Massed Mailings (MM) condition, which will receive all 8 booklets in a single mailing.

Official Title
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Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking Cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referrals from the New York State Smokers' Quitline at least 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care (UC)<br>Receive Quitline services | Behavioral: Smoking Cessation<br>* Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.<br>* Other names: Forever Free;|
| Active Comparator: Repeated Mailings (RM)<br>Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months | Behavioral: Smoking Cessation<br>* Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.<br>* Other names: Forever Free;|
| Active Comparator: Massed Mailings (MM)<br>Receive all 8 booklets in a single mailing | Behavioral: Smoking Cessation<br>* Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.<br>* Other names: Forever Free;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Day Point-Prevalence Abstinence at Each Follow-up Point | To test the effectiveness of a self-help, relapse-prevention intervention (Forever Free booklets) as an adjunct to a state telephone quitline | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self help, smoking cessation, cancer prevention