Internet and Telephone Counseling for Smoking Cessation - Full Text View

Sponsors and Collaborators:	Lombardi Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00282009

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	Procedure: counseling Procedure: internet-based intervention Procedure: psychosocial assessment and care Procedure: smoking cessation intervention

MedlinePlus related topics: Cancer Quitting Smoking Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
Official Title:	Internet and Telephone Counseling for Smoking Cessation

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment [ Designated as safety issue: No ]

Estimated Enrollment:	2205
Study Start Date:	August 2004

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

Lombardi Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Amanda L. Graham, PhD

Lombardi Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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:S49-57.

Other 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:S43-8.

Publications indexed to this study:

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.

Study ID Numbers:	CDR0000465179, GUMC-5-R01CA104836, RWMC-5-R01CA104836
Study First Received:	January 24, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00282009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Smoking

ClinicalTrials.gov processed this record on January 16, 2009