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

Primary Purpose

Cigarette Smoking, Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Smoking Cessation Web Site
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cigarette Smoking focused on measuring cigarette smoking behavior, smoking cessation, Latino smoking cessation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care for Smoking

Internet Smoking Cessation Web Site

Arm Description

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

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

Outcomes

Primary Outcome Measures

smoking abstinence
no cigarettes smoked in the week and/or month prior to completion of the follow-up survey

Secondary Outcome Measures

Smoking fewer cigarettes
Reduction in the average number of cigarettes smoked per day

Full Information

First Posted
July 10, 2012
Last Updated
November 13, 2018
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01639079
Brief Title
Comparison of Internet Stop Smoking Intervention to Usual Care on Smoking Cessation at 6 Months
Acronym
TC5Redes
Official Title
Smoking Cessation Through the Web: Latino Smokers Follow-Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Nicotine Dependence
Keywords
cigarette smoking behavior, smoking cessation, Latino smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care for Smoking
Arm Type
No Intervention
Arm Description
Usual care for smoking cessation with access to the web site after 6 months
Arm Title
Internet Smoking Cessation Web Site
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Internet Smoking Cessation Web Site
Other Intervention Name(s)
Tomando Control, UCSF Stop Smoking Web Site
Intervention Description
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
Primary Outcome Measure Information:
Title
smoking abstinence
Description
no cigarettes smoked in the week and/or month prior to completion of the follow-up survey
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Smoking fewer cigarettes
Description
Reduction in the average number of cigarettes smoked per day
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo F. Muñoz, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0320
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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