Literacy and Smoking Risk Communications

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00684437
First received: May 22, 2008
Last updated: July 3, 2014
Last verified: July 2014
  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 ]

Enrollment: 495
Study Start Date: May 2008
Primary Completion Date: June 2014 (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
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: NCT00684437

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
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, 1R01CA125413-01
Study First Received: May 22, 2008
Last Updated: July 3, 2014
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 July 20, 2014