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Internet and Telephone Counseling for Smoking Cessation

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 25, 2006
Last Update Posted: February 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
January 24, 2006
January 25, 2006
February 10, 2016
August 2004
October 2015   (Final data collection date for primary outcome measure)
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment [ Time Frame: 12 months ]
Not Provided
Complete list of historical versions of study NCT00282009 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Internet and Telephone Counseling for Smoking Cessation
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.


  • 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.

Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Unspecified Adult Solid Tumor, Protocol Specific
  • Behavioral: Basic Internet
    Basic Internet control intervention
  • Behavioral: Enhanced Internet
    enhanced Internet cessation intervention
  • Behavioral: Enhanced Internet + phone
    enhanced Internet plus proactive telephone counseling
  • Active Comparator: Basic Internet
    Basic Internet
    Intervention: Behavioral: Basic Internet
  • Experimental: Enhanced Internet
    Enhanced Internet
    Intervention: Behavioral: Enhanced Internet
  • Experimental: Enhanced Internet plus Phone
    Enhanced Internet + proactive telephone counseling
    Intervention: Behavioral: Enhanced Internet + phone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2015
October 2015   (Final data collection date for primary outcome measure)


  • 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


  • Not specified


  • Not specified
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01CA104836 ( U.S. NIH Grant/Contract )
Not Provided
Plan to Share IPD: No
Georgetown University
Georgetown University
National Cancer Institute (NCI)
Principal Investigator: Amanda L. Graham, PhD Lombardi Comprehensive Cancer Center
Georgetown University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP