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

NCT ID: NCT01639079

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Cigarette Smoking; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care for Smoking

Usual care for smoking cessation with access to the web site after 6 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Internet Smoking Cessation Web Site

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Tomando Control; UCSF Stop Smoking Web Site

Eligibility 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

Note - You do not need to contact anyone to begin this study. Please access the following URLs to participate: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo F. Muñoz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

U01CA086117

Identifier Type: NIH

Identifier Source: secondary_id

View Link

REDES-EPS-LAT-SMK-5

Identifier Type: -

Identifier Source: org_study_id