Internet and Telephone Counseling for Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00282009
First received: January 24, 2006
Last updated: August 13, 2014
Last verified: August 2014

January 24, 2006
August 13, 2014
August 2004
October 2009   (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 ] [ Designated as safety issue: No ]
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Unspecified Adult Solid Tumor, Protocol Specific
  • Behavioral: smoking cessation intervention
    subjects will receive either internet or telephone counseling
  • Other: counseling intervention
    telephone or internet counseling
  • Other: internet-based intervention
    internet based counseling
  • Behavioral: psychosocial assessment and care
    psychosocial assessment and counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2205
December 2014
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00282009
CDR0000465179, R01CA104836, GUMC-5-R01CA104836, RWMC-5-R01CA104836
No
Georgetown University
Georgetown University
National Cancer Institute (NCI)
Principal Investigator: Amanda L. Graham, PhD Lombardi Cancer Research Center
Georgetown University
August 2014

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