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

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Smoking Cessation

• Registration Number: NCT01352000
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3830

Inclusion Criteria

• referrals from the New York State Smokers' Quitline
• at least 18 years of age

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated Mailings (RM)	Smoking Cessation	Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months
Massed Mailings (MM)	Smoking Cessation	Receive all 8 booklets in a single mailing
Usual Care (UC)	Smoking Cessation	Receive Quitline services

Primary Outcome Measures

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

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States