Trial record 17 of 422 for:    Open Studies | "Smoking"

Comparison of Internet Stop Smoking Intervention to Usual Care on Smoking Cessation at 6 Months (TC5Redes)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01639079
First received: July 10, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

The primary goal of this project is to carry out a randomized controlled trial (RCT) comparing quit rates of a Spanish/English stop smoking Web site to those of a no-intervention or "quit on your own" control. The investigators have not included a no-intervention condition in previous Web studies and although 20% of participants quit smoking at one year are 20%, obtaining evidence that the investigators interventions yield higher abstinence rates than a no-intervention control is the next logical step. Furthermore, although the investigators Web site was designed in English and Spanish, the investigators success in attracting the U.S. Hispanic/Latino (HL) population in either language has been limited, so this project only will only conduct intensive telephone follow-up of HL smokers and add new recruitment methods to do so.


Condition Intervention Phase
Cigarette Smoking
Nicotine Dependence
Behavioral: Internet Smoking Cessation Web Site
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation Through the Web: Latino Smokers Follow-Up Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • smoking abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    no cigarettes smoked in the week and/or month prior to completion of the follow-up survey


Secondary Outcome Measures:
  • Smoking fewer cigarettes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Reduction in the average number of cigarettes smoked per day


Estimated Enrollment: 10000
Study Start Date: June 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care for Smoking
Usual care for smoking cessation with access to the web site after 6 months
Experimental: Internet Smoking Cessation Web Site

Internet Stop Smoking site (TC5) offers a menu of several intervention elements from which the participants may choose as many as they wish. The links (URLs) to register for the study are:

English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx

Behavioral: Internet Smoking Cessation Web Site
Internet Stop Smoking site (TC5) with several intervention elements from which the participants may choose as many as they wish. The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx
Other Names:
  • Tomando Control
  • UCSF Stop Smoking Web Site

Detailed Description:

The main study will randomize participants to one of two conditions, an intervention condition ("immediate") and a no-intervention control ("delayed"). For the control "quit on your own" condition, we will offer a 6-month "Delayed" treatment condition (DC) and will inform participants that we are testing whether smokers who are motivated enough to seek Internet information on smoking cessation can quit on their own at the same rate as smokers who are given access to an interactive stop smoking Web site. For our intervention, the "Immediate" treatment condition (IC) is the UCSF Spanish/English Stop Smoking research Web site (www.stopsmoking.ucsf.edu) that provides smokers their preference of all elements tested in earlier trials: 1) a Web version of a National Cancer Institute-designated evidence-based intervention with updated content, the Guía para Dejar de Fumar; 2) A document summarizing pharmacological treatment to aide smoking cessation available over the counter such as nicotine gum or patch or by prescriptions from a clinician; 3) e-mail reminders to return to the site timed to individually set quit dates; 4) a mood management smoking cessation intervention; and 5) a virtual group (an asynchronous bulletin board designed to let participants provide mutual support). We will recruit study participants until we have randomized 1200 HL smokers in English or Spanish stratified by gender within language group. Participants will be followed at 1, 3, 6, and 12 months after randomization to obtain self-reported prolonged abstinence and 7- and 30-day time point prevalence rates. E-mail reminders will be sent to remind participants to return to the site to complete follow-up surveys online. Only HL smokers from the US will be followed up by telephone calls at 1 and 6 months. The main comparison measure will be cessation at 6 and 12 months from original randomization. DC participants will be able to access the interactive site after finishing the 6-month follow-up. We plan to attract Spanish-speaking HL participants to our Web site using Spanish-language TV and radio interviews and public service announcements (PSA), Spanish-language Google ads and networking with U.S. cessation groups.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 or older
  • daily (smoking one or more cigarettes per day) or non-daily (smoke some days) smoker
  • planning to quit within the next month
  • have a valid e-mail address so to send a password required to consent online.
  • speak English or Spanish
  • consent to participate

Exclusion Criteria:

  • does not speak English or Spanish
  • age younger than 18 years
  • non-smoker
  • no valid email address
  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: NCT01639079

Contacts
Contact: Eliseo J. Perez-Stable, MD 415 514 8662 eliseops@medicine.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143-0320
Contact: Cecilia Populus-Eudave    415-502-4088    ceciliap@medicine.ucsf.edu   
Contact: Anna M Napoles, PhD    415 476-6290    anapoles@ucsf.edu   
Principal Investigator: Eliseo J Perez-Stable, MD         
Sub-Investigator: Ricardo F Muñoz, PhD         
Sub-Investigator: Anna M Napoles, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Eliseo J Perez-Stable, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01639079     History of Changes
Other Study ID Numbers: REDES-EPS-LAT-SMK-5, U01CA086117
Study First Received: July 10, 2012
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
cigarette smoking behavior
smoking cessation
Latino smoking cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on July 29, 2014