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

Smoking Cessation Clinical Trial

Official title:

Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352000
• Other study ID #: MCC-15725
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: February 21, 2017
• Start date: December 2008
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3830
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• referrals from the New York State Smokers' Quitline

• at least 18 years of age

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Smoking Cessation
Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI), Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website