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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01352000
First received: May 10, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
 Behavioral: Smoking Cessation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • 7-Day Point-Prevalence Abstinence at Each Follow-up Point [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To test the effectiveness of a self-help, relapse-prevention intervention (Forever Free booklets) as an adjunct to a state telephone quitline


Enrollment: 3830
Study Start Date: December 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • referrals from the New York State Smokers' Quitline
  • at least 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352000

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Investigators
Principal Investigator: Thomas Brandon, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01352000     History of Changes
Other Study ID Numbers: MCC-15725
Study First Received: May 10, 2011
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
self help
smoking cessation
cancer prevention

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013