Overview

This trial has been completed.

Condition smoking cessation
Treatment smoking cessation
Phase phase 3
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator National Cancer Institute (NCI)
Start date December 2008
End date October 2016
Trial size 3830 participants
Trial identifier NCT01352000, MCC-15725

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Receive Quitline services
smoking cessation Quitline
Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.
(Active Comparator)
Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months
smoking cessation Quitline
Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.
(Active Comparator)
Receive all 8 booklets in a single mailing
smoking cessation Quitline
Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.

Primary Outcomes

Measure
7-Day Point-Prevalence Abstinence at Each Follow-up Point
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline
Principal investigator Thomas Brandon, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.