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: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: smoking cessation intervention
Other: counseling intervention
Other: internet-based intervention
Behavioral: psychosocial assessment and care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Internet and Telephone Counseling for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2205
Study Start Date: August 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282009

Locations
United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Amanda L. Graham, PhD Lombardi Cancer Research Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00282009     History of Changes
Other Study ID Numbers: CDR0000465179, R01CA104836, GUMC-5-R01CA104836, RWMC-5-R01CA104836
Study First Received: January 24, 2006
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 23, 2014