- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282009
Internet and Telephone Counseling for Smoking Cessation
RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking. It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the efficacy of premium internet intervention vs premium internet with telephone intervention vs basic internet intervention, as determined by 7-day point prevalence abstinence at 12 months, in adult smokers.
- Compare the cost-effectiveness of these interventions in promoting smoking cessation.
- Determine the effects of internet-based interventions on measured use of the intervention (frequency and duration of use, utilization of behavioral coping, expert advices, and e-mail) in these patients.
- Determine the effects of internet-based interventions on variables important for behavior change including mediators (e.g., self-efficacy, use of internet social support) and moderators (e.g., gender, baseline motivation) of outcomes in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to gender and baseline motivation level. Patients are randomized to 1 of 3 intervention arms.
- Arm I (basic internet program): Patients are directed to a website of existing QuitNet™ smoking cessation materials. These materials are not tailored and have no interactive features.
- Arm II (premium internet program): Patients receive free 6-month access to the QuitNet™ website including interactive and individualized intervention features.
- Arm III (premium internet program plus telephone counseling): Patients receive free access to the QuitNet™ website as in arm II. Patients also receive up to 5 telephone counseling sessions, scheduled at their convenience.
All patients are assessed at baseline and then at 3, 6, 12, and 18 months.
PROJECTED ACCRUAL: A total of 2,205 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Smokes at least 5 cigarettes a day
- No prior use of QuitNet website
- Must have access to the internet and a telephone at home or work
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Basic Internet
|
Basic Internet control intervention
|
Experimental: Enhanced Internet
|
enhanced Internet cessation intervention
|
Experimental: Enhanced Internet plus Phone
Enhanced Internet + proactive telephone counseling
|
enhanced Internet plus proactive telephone counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda L. Graham, PhD, Lombardi Comprehensive Cancer Center
Publications and helpful links
General Publications
- Graham AL, Bock BC, Cobb NK, Niaura R, Abrams DB. Characteristics of smokers reached and recruited to an internet smoking cessation trial: a case of denominators. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S43-8. doi: 10.1080/14622200601042521.
- Graham AL, Papandonatos GD, Bock BC, Cobb NK, Baskin-Sommers A, Niaura R, Abrams DB. Internet- vs. telephone-administered questionnaires in a randomized trial of smoking cessation. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S49-57. doi: 10.1080/14622200601045367.
- Graham AL, Papandonatos GD. Reliability of internet- versus telephone-administered questionnaires in a diverse sample of smokers. J Med Internet Res. 2008 Mar 26;10(1):e8. doi: 10.2196/jmir.987.
- Graham AL, Cobb NK, Papandonatos GD, Moreno JL, Kang H, Tinkelman DG, Bock BC, Niaura RS, Abrams DB. A randomized trial of Internet and telephone treatment for smoking cessation. Arch Intern Med. 2011 Jan 10;171(1):46-53. doi: 10.1001/archinternmed.2010.451. Erratum In: Arch Intern Med. 2011 Mar 14;171(5):395.
- Graham AL, Papandonatos GD, Kang H, Moreno JL, Abrams DB. Development and validation of the online social support for smokers scale. J Med Internet Res. 2011 Sep 28;13(3):e69. doi: 10.2196/jmir.1801.
- Graham AL, Chang Y, Fang Y, Cobb NK, Tinkelman DS, Niaura RS, Abrams DB, Mandelblatt JS. Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study. Tob Control. 2013 Nov;22(6):e11. doi: 10.1136/tobaccocontrol-2012-050465. Epub 2012 Sep 25.
- Cobb CO, Niaura RS, Donaldson EA, Graham AL. Quit now? Quit soon? Quit when you're ready? Insights about target quit dates for smoking cessation from an online quit date tool. J Med Internet Res. 2014 Feb 17;16(2):e55. doi: 10.2196/jmir.3086.
- Cobb CO, Graham AL. Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation. Nicotine Tob Res. 2014 Oct;16(10):1289-97. doi: 10.1093/ntr/ntu066. Epub 2014 May 8.
- Graham AL, Papandonatos GD, Cobb CO, Cobb NK, Niaura RS, Abrams DB, Tinkelman DG. Internet and Telephone Treatment for smoking cessation: mediators and moderators of short-term abstinence. Nicotine Tob Res. 2015 Mar;17(3):299-308. doi: 10.1093/ntr/ntu144. Epub 2014 Aug 25.
- Graham AL, Papandonatos GD, Erar B, Stanton CA. Use of an online smoking cessation community promotes abstinence: Results of propensity score weighting. Health Psychol. 2015 Dec;34S(0):1286-95. doi: 10.1037/hea0000278.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CDR0000465179
- R01CA104836 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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