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Capitalizing on a Teachable Moment to Promote Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
James and Esther King Biomedical Research Program
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT02276664
First received: October 21, 2014
Last updated: April 27, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.

Condition Intervention
Smoking Cessation
Behavioral: Self-Help (SHI)
Behavioral: Usual Care (UC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Capitalizing on a Teachable Moment to Promote Smoking Cessation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Study 1 - Completion of Formative Evaluation [ Time Frame: Up to 12 months ]
    Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.

  • Study 2 - Rate of Seven-Day Abstinence [ Time Frame: Seven-day abstinence will be assessed at each follow-up, allowing for calculation of point-prevalence abstinence rates. For this pilot, we will not bioverify self-reported abstinence. ]
    Up to 9 months


Secondary Outcome Measures:
  • Rate of Intervention Demand [ Time Frame: Up to 9 months ]
    Demand will be estimated by noting accrual rates into the study.

  • Degree of Practicality [ Time Frame: Up to 9 months ]
    Practicality encompasses the degree to which investigators are able to carry out all the piloted elements of the planned randomized control trial (RCT) successfully and efficiently (i.e., recruitment, screening, randomization, and follow-up).


Enrollment: 35
Actual Study Start Date: October 20, 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Study 1 - Focus Groups
Using focus group methodology, investigators will identify and explore new content topics for inclusion in smoking cessation booklets and gather feedback about the existing Stop Smoking for Good booklets regarding tone and message design. Results will be used to modify and adapt the existing cessation intervention.
Experimental: Study 2 - Self-Help Intervention (SHI)
The SHI arm will receive the intervention developed in Study I.
Behavioral: Self-Help (SHI)
The newly revised Stop Smoking for Good booklets.
Active Comparator: Study 2 - Usual Care (UC)
The UC arm will receive the existing Clearing the Air smoking-cessation manual.
Behavioral: Usual Care (UC)
The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).

Detailed Description:

Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.

Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.

Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.

  Eligibility

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

Inclusion Criteria:

Study 1

  • Participants for Study I will be drawn from a list of patients who have received a CT scan at the Moffitt Cancer Center
  • Smoked at least one cigarette per week prior to undergoing the CT scan
  • Able to speak and read English

Study 2

  • Smoked at least one cigarette over the past week
  • Able to read English
  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: NCT02276664

Locations
United States, Florida
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
Investigators
Principal Investigator: Thomas Brandon, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02276664     History of Changes
Other Study ID Numbers: MCC-17952
4KB05 ( Other Identifier: James and Esther King Biomedical Research Program )
Study First Received: October 21, 2014
Last Updated: April 27, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
lung cancer prevention

ClinicalTrials.gov processed this record on May 25, 2017