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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01639079
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : April 19, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Cigarette Smoking Nicotine Dependence Behavioral: Internet Smoking Cessation Web Site Phase 4

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 ( 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation Through the Web: Latino Smokers Follow-Up Study
Study Start Date : June 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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: Spanish:

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: Spanish:
Other Names:
  • Tomando Control
  • UCSF Stop Smoking Web Site

Primary Outcome Measures :
  1. smoking abstinence [ Time Frame: 6 months ]
    no cigarettes smoked in the week and/or month prior to completion of the follow-up survey

Secondary Outcome Measures :
  1. Smoking fewer cigarettes [ Time Frame: 6 months ]
    Reduction in the average number of cigarettes smoked per day

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Note - You do not need to contact anyone to begin this study. Please access the following URLs to participate: English: Spanish:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01639079

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0320
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Ricardo F. Muñoz, PhD University of California, San Francisco

Additional Information:
Responsible Party: University of California, San Francisco Identifier: NCT01639079     History of Changes
Other Study ID Numbers: REDES-EPS-LAT-SMK-5
U01CA086117 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders