Capitalizing on a Teachable Moment to Promote Smoking Cessation

NCT02276664 | Completed

• 2 other identifiers: MCC-179524KB05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

lung cancer prevention

Outcome Measures

Primary Outcomes (2)

• Study 1 - Completion of Formative Evaluation

  Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.

  Up to 12 months

• Study 2 - Rate of Seven-Day Abstinence

  Up to 9 months

  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.

Secondary Outcomes (2)

• Rate of Intervention Demand

  Up to 9 months

• Degree of Practicality

  Up to 9 months

Study Arms (3)

Study 1 - Focus Groups

NO INTERVENTION

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.

Study 2 - Self-Help Intervention (SHI)

EXPERIMENTAL

The SHI arm will receive the intervention developed in Study I.

Behavioral: Self-Help (SHI)

Study 2 - Usual Care (UC)

ACTIVE COMPARATOR

The UC arm will receive the existing Clearing the Air smoking-cessation manual.

Behavioral: Usual Care (UC)

Interventions

Self-Help (SHI) BEHAVIORAL

The newly revised Stop Smoking for Good booklets.

Study 2 - Self-Help Intervention (SHI)

Usual Care (UC) BEHAVIORAL

The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).

Study 2 - Usual Care (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• James and Esther King Biomedical Research Program: collaborator

Study Sites (1)

H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

National Health Programs

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations

Study Officials

• Thomas Brandon, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: October 20, 2014
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

US (1)