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

February 21, 2017 updated by: H. Lee Moffitt Cancer Center and Research Institute

Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care (UC)
Receive Quitline services
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.
Other Names:
  • Quitline
  • NYSSQL
  • relapse-prevention
  • Forever Free
ACTIVE_COMPARATOR: Repeated Mailings (RM)
Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months
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.
Other Names:
  • Quitline
  • NYSSQL
  • relapse-prevention
  • Forever Free
ACTIVE_COMPARATOR: Massed Mailings (MM)
Receive all 8 booklets in a single mailing
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.
Other Names:
  • Quitline
  • NYSSQL
  • relapse-prevention
  • Forever Free

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)
Roswell Park Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (ESTIMATE)

May 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-15725

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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