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

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ClinicalTrials.gov Identifier: NCT01352000
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Smoking Cessation Behavioral: Smoking Cessation

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  (Clinical Trial)
Actual Enrollment : 3830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline
Study Start Date : December 2008
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01352000     History of Changes
Other Study ID Numbers: MCC-15725
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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