Reaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers

This study has been completed.
Sponsor:
Collaborator:
California Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Gary Humfleet, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00634218
First received: March 4, 2008
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

Smoking rates are significantly higher among lesbian, gay, bisexual, and transgender (LGBT) populations compared to the general population. LGBT individuals may be at increased risk for experiencing psychosocial issues, e.g., negative moods, stress, alcohol/drug use, that have been associated with smoking treatment failure in other groups of smokers. Technology, such as the Internet and telephone, can be an effective method to reach a large number of smokers and may be particularly effective in reaching hidden populations. Thus, the study seeks to examine whether Internet-based counseling and/or telephone counseling can improve quit rates for LGBT smokers.

Participants (N=600) will be randomly assigned to one of four conditions: 1) a Mail-based Self Help (MSH) treatment; 2) MSH plus an Internet-based Smoking Treatment (IST); MSH plus Telephone Counseling (TC) or 4) MSH plus IST plus TC. Participants in the MSH condition will receive a self-help smoking cessation manual. In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support. In the TC condition, participants will receive the manual plus 6 telephone-based counseling sessions. In the fourth condition, participants will receive the manual plus access to an Internet-based intervention plus telephone counseling. Before starting treatment, participants will complete questionnaires on smoking, nicotine dependence, demographics, negative mood, and alcohol use. Participants will be contacted at 3, 6, and 12 months after enrollment to determine whether they are smoking. The data will be analyzed to compare the efficacy of the four treatments and to examine the possible influence of existing social networks and level of negative mood on treatment outcome and to examine the possible influence of residency (rural versus urban) on use of the Internet-based treatment.


Condition Intervention Phase
Cigarette Smoking
Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment
Behavioral: Self-Help Manual plus Telephone counseling
Behavioral: Self-Help Manual
Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: REaching and Treating LGBT Smokers: The Internet

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Smoking status [ Time Frame: 3,6, and 12 months following enrollment. ] [ Designated as safety issue: No ]

Enrollment: 363
Study Start Date: February 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mail-based Self Help (MSH) treatment. Participants will receive the self-help manual developed specifically for LGBT smokers.
Behavioral: Self-Help Manual
Participants will receive a self-help smoking cessation manual specifically developed for LGBT smokers. The manual provides information on quitting smoking and encourages the development of a personalized quit plan through various activities and exercises.
Active Comparator: 2
Mail-based Self Help plus an Internet-based Smoking Treatment (IST). In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support.
Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment
Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants.
Active Comparator: 3
Mail-based Self-Help plus Telephone Counseling (TC). In the TC condition, participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions.
Behavioral: Self-Help Manual plus Telephone counseling
Participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions. The counseling sessions focus on the development of a personalized plan to quit smoking and occur over a 3 month period.
Active Comparator: 4
Mail-based Self-Help plus an Internet-based Intervention plus Telephone Counseling. Participants will receive a self-help manual, have access to an internet-based smoking treatment and participante in 6 telephone counseling sessions.
Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling
Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants. Smokers will also receive 6 telephone-based counseling sessions which occur over a 3 month period

  Eligibility

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

Inclusion Criteria:

  • 18 years of age
  • identify as lesbian, gay, bisexual, or transgender
  • access to the internet
  • valid email account
  • valid telephone number
  • English speaking
  • resident of the U.S.

Exclusion Criteria:

-

  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: NCT00634218

Locations
United States, California
Univeristy of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
California Tobacco Related Disease Research Program
  More Information

No publications provided

Responsible Party: Gary Humfleet, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00634218     History of Changes
Other Study ID Numbers: TRDRP 15RT-0165
Study First Received: March 4, 2008
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
nicotine
smoking
smoking cessation

ClinicalTrials.gov processed this record on September 16, 2014