Literacy and Smoking Risk Communications

This study is currently recruiting participants.
Verified November 2013 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00684437
First received: May 22, 2008
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., inadequate, marginal, adequate) recruited from the community will listen to one of 4 different types of messages emphasizing the health consequences of smoking recorded on a computer in the form of audio scripts (i.e., a human voice pre-recorded on a computer will read each message). Messages written at a 5th to 6th grade reading level will be concurrently presented in written form via a computer monitor and be manipulated in terms of 1) emotionality (i.e., primarily fact- vs. primarily emotion-based), and 2) framing (i.e., gain-framed messages that highlight the potential benefits of quitting smoking vs. loss-framed messages that emphasize the potential costs of failing to quit smoking). Emotionality and framing will be completely crossed to create four different types of messages, 1) factual gain-framed (FGF), 2) factual loss-framed (FLF), 3) emotional gain-framed (EGF), and 4) emotional loss-framed (ELF).

The primary objectives are to:

  1. Examine whether main effects emerge for health literacy as assessed by the S-TOFHLA (inadequate, marginal, adequate) and the different message types (fact- vs. emotion-based and gain- vs. loss-framed) on the primary explicit and implicit outcomes: a) intention to quit, and b) implicit and explicit attitudes toward smoking.
  2. Examine whether health literacy interacts with the different types of messages (fact-based vs. emotion-based and gain-framed vs. loss-framed) to influence the primary explicit and implicit outcome measures: a) intention to quit smoking, and b) implicit and explicit attitudes toward smoking.

    A secondary, exploratory aim is to:

  3. Examine potential associations between a) the primary explicit and implicit outcomes, and b) the secondary explicit and implicit outcomes: knowledge, risk perception, attitudes, self-efficacy, message evaluations, implicit fear of disease, and implicit associations between smoking and disease.

Condition Intervention
Smoking
Behavioral: Focus Group
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Literacy and Smoking Risk Communications

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Factors that may influence how smokers understand smoking health risk informational messages. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2008
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Factual Gain-Framed
Smoking Risk Message - Factual Gain-Framed (FGF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey
Experimental: Factual Loss-Framed
Smoking Risk Message - Factual Loss-Framed (FLF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey
Experimental: Emotional Gain-Framed
Smoking Risk Message - Emotional Gain-Framed (EGF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey
Experimental: Emotional Loss-Framed
Smoking Risk Message - Emotional Loss-Framed (ELF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 18 to 70 years
  2. current smoker with a history of at least 5 cigarettes/day for the last year
  3. can speak, read, and write in English
  4. home address and a functioning home telephone number

Exclusion Criteria:

  1. age 18 to 70 years
  2. current smoker with a history of at least 5 cigarettes/day for the last year
  3. can speak, read, and write in English
  4. home address and a functioning home telephone number

Exclusion:

  1. current use of nicotine replacement therapy or bupropion
  2. current enrollment in a smoking cessation treatment program
  3. expired CO<10 ppm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684437

Contacts
Contact: Jennifer Irvin Vidrine, PhD 713-745-2383

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jennifer Irvin Vidrine, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jennifer Irvin Vidrine, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00684437     History of Changes
Other Study ID Numbers: 2006-0699
Study First Received: May 22, 2008
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Health Literacy
Smoking Risk
Focus Group
Questionnaire
Survey

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 22, 2014