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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 13, 2014
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 August 26, 2014