Viewing Study NCT01639079



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Study NCT ID: NCT01639079
Status: COMPLETED
Last Update Posted: 2018-11-15
First Post: 2012-07-10

Brief Title: Comparison of Internet Stop Smoking Intervention to Usual Care on Smoking Cessation at 6 Months
Sponsor: University of California San Francisco
Organization: University of California San Francisco

Study Overview

Official Title: Smoking Cessation Through the Web Latino Smokers Follow-Up Study
Status: COMPLETED
Status Verified Date: 2018-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TC5Redes
Brief Summary: The primary goal of this project is to carry out a randomized controlled trial RCT comparing quit rates of a SpanishEnglish 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 US HispanicLatino 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 SpanishEnglish Stop Smoking research Web site wwwstopsmokingucsfedu 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 US cessation groups

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U01CA086117 NIH None httpsreporternihgovquickSearchU01CA086117