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Evaluation of National Cancer Institute Young Adult Stop-Smoking Program

This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01885052
First received: June 20, 2013
Last updated: March 14, 2014
Last verified: May 2013
  Purpose

Background:

- Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29 stop smoking. This is part of a larger online stop-smoking program by the National Cancer Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks of follow-up messages. Program participants will receive texts on their cell phones, including tips, information, and motivational messages, and then fill out surveys.

Objectives:

- To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.

Eligibility:

- Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop smoking in the next 30 days.

Design:

  • Participants will receive a certain number of text messages during the 8-week study. They will receive between 0 to 5 messages per day (or up to a total of 130 messages).
  • Participants will first fill out a survey about their smoking and quitting experiences. Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after this survey.
  • Participants will take four other surveys online, one during the program and three more after they ve completed the program. Each survey will take about 10 20 minutes and asks about their smoking habits and views on smoking and quitting. Each survey will be sent by email, with reminders sent by email or telephone.
  • Participants will receive an iTunes or Amazon gift card for completing each survey honestly.

Condition Intervention Phase
Smoking
Smoking Cessation
Cigarette Smoking
Tobacco, Smoking
Behavioral: Smoking cessation text messaging
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: NCI Young Adult Smoking Cessation Evaluation

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Key outcome variables included cessation initiation, cessation maintenance, relapse, reduction in cigarette smoking, and period of abstinence from smoking. [ Time Frame: Assessed at multiple points during the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In addition, the evaluation will explore whether engagement with the text messaging features (beyond mere exposure) results in cessation-related outcomes. [ Time Frame: Assessed at multiple points during the trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 4248
Study Start Date: June 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full Text Program Behavioral: Smoking cessation text messaging
N/A
Active Comparator: Moderate Text Program Behavioral: Smoking cessation text messaging
N/A
Active Comparator: Minimal Text Program Behavioral: Smoking cessation text messaging
N/A

Detailed Description:

This study seeks to assess the effectiveness of the QuitTXT program, a text message cessation intervention designed for young adult smokers ages 18-29. The QuitTXT program is a component of a larger web-based tobacco cessation intervention resource provided by the National Cancer Institute. The program focuses on providing actionable strategies and fact based information, serving as an engagement tool delivering two-way communication, and delivering intra- and extra-treatment support. The structure of the QuitTXT program is designed as a 14-day countdown to quit date with subsequent six weeks of messages. Throughout the program, users will receive texts that cover a variety of content areas including tips, informational content, motivational messaging, and keyword responses.

The study seeks to recruit a large sample of young adult smokers ages 18-29 to examine how exposure to the QuitTXT program affects participants.

There will be 3-arms to the study:

Participants in Arm 1, the control group of the study, will only receive the weekly assessments asking them of their smoking status.

Participants in Arm 2 will receive a texting program that consists of up to two weeks of countdown to quit messaging plus assessments messages that all groups receive for a total of 8 weeks.

Participants in Arm 3 will receive the full text messaging program.

All groups will be able to select a quit date within a 7-day window (between 2 and 3 weeks after they complete the baseline survey). Participants in Arm 3 will receive motivational/informational messages while participants in group 1 will receive only assessment messages. Participants in Arm 2 will receive the countdown messages to their quit date, but not the motivational messaging after their quit date. Like Arm 1, they will only receive assessment messages after their quit date.

This study will add unique value to the existing literature by teasing out the effect of some messages vs. frequent, motivational/informational messaging on quit rates and intent to quit among young adults.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • For this study, we will recruit smokers aged 18 to 29 who have smoked on at least 5 of the last 30 days and who are interested in stopping smoking in the next 30 days. To be eligible, a young adult must meet the following criteria:

Ages 18-29 years

Reside in the US

Smoke cigarettes at least 5 days/month

Be interested in quitting cigarette use

Not be involved in a cessation program

Have an active email account

Be able to receive text messages on their cell phone

Be the only member of your household participating in this study

Be willing to share contact information with the study team in order to share information about the study on a timely basis.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885052

Contacts
Contact: Erik M Augustson, Ph.D. (301) 451-5048 augustse@mail.nih.gov

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Erik M Augustson, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01885052     History of Changes
Other Study ID Numbers: 999913156, 13-C-N156
Study First Received: June 20, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Smoking Cessation Clinical Trial
Text Messaging Program
Smoking Cessation Aid

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 17, 2014