Back to resultsRelapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")
Primary Purpose
Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Cessation
Sponsored by
About this trial
This is an interventional prevention trial for Smoking Cessation focused on measuring self help, smoking cessation, cancer prevention
Eligibility Criteria
Inclusion Criteria:
- referrals from the New York State Smokers' Quitline
- at least 18 years of age
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Usual Care (UC)
Repeated Mailings (RM)
Massed Mailings (MM)
Arm Description
Receive Quitline services
Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months
Receive all 8 booklets in a single mailing
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01352000
First Posted
May 10, 2011
Last Updated
February 21, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01352000
Brief Title
Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")
Official Title
Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), Roswell Park Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
self help, smoking cessation, cancer prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3830 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care (UC)
Arm Type
Active Comparator
Arm Description
Receive Quitline services
Arm Title
Repeated Mailings (RM)
Arm Type
Active Comparator
Arm Description
Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months
Arm Title
Massed Mailings (MM)
Arm Type
Active Comparator
Arm Description
Receive all 8 booklets in a single mailing
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation
Other Intervention Name(s)
Quitline, NYSSQL, relapse-prevention, Forever Free
Intervention Description
Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.
Primary Outcome Measure Information:
Title
7-Day Point-Prevalence Abstinence at Each Follow-up Point
Description
To test the effectiveness of a self-help, relapse-prevention intervention (Forever Free booklets) as an adjunct to a state telephone quitline
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
referrals from the New York State Smokers' Quitline
at least 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Brandon, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")
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