Extended Self-Help for Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01352195
First received: May 10, 2011
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

The primary purpose of this study is smoking cessation. The investigators are conducting a research study to learn how well the information from the program helps participants to quit smoking and remain smoke-free.


Condition Intervention Phase
Smoking Cessation
Behavioral: Forever Free Booklets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Extended Self-Help for Smoking Cessation

Resource links provided by NLM:


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: 30 months per participant ] [ Designated as safety issue: No ]
    Time will be measured in months from the start of condition. Potential confounding variables (e.g., group differences in demographic, smoking history, or pharmacotherapy use) will be adjusted for in the model. Pair-wise condition and time interval comparisons will be tested using the generalized score statistics from generalized estimating equations (GEE) models by utilizing the contrast statements.


Enrollment: 2124
Study Start Date: January 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care (UC)
This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003).
Behavioral: Forever Free Booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
Active Comparator: Standard Repeated Mailings (Stand-RM)
Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies.
Behavioral: Forever Free Booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
Active Comparator: Intensive Repeated Mailings (Inten-RM)
Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts.
Behavioral: Forever Free Booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.

Detailed Description:

The investigators propose a randomized 3-arm design, with 660 smokers recruited into each condition. The three conditions will include: (1) Usual care (UC), which will comprise a single smoking cessation booklet developed by NCI; (2) Standard Repeated Mailings (Stand-RM), which will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies; and (3) Intensive Repeated Mailings (Inten-RM), which will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. Assessments will occur at six-month intervals, through 30 months. An overview of the design is depicted in Table 4, which will be referenced throughout the remainder of this proposal.

  Eligibility

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

Participants:

  • Planned Participants: 1980 daily smokers (for a final sample of at least 1584 after attrition), recruited via multimedia advertisements (daily and weekly newspapers, radio, cable television, public transit ads, etc.), public service announcements, and direct community engagement.

Inclusion Criteria:

  • smoking at least five cigarette per day over the past year
  • not currently enrolled in a face-to-face smoking cessation program
  • able to speak and read English
  • desire to quit smoking, as indicated by a score of at least 5 ("Think I should quit, but not quite ready") on the Contemplation Ladder (Biener & Abrams, 1991)

Exclusion Criteria:

  • we will limit the number of participants from the same street address to 1
  • we not allow more than 2 referrals per participant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352195

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
Investigators
Principal Investigator: Thomas Brandon, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01352195     History of Changes
Other Study ID Numbers: MCC-15724
Study First Received: May 10, 2011
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Forever Free

ClinicalTrials.gov processed this record on September 18, 2014