Internet and Telephone Counseling for Smoking Cessation - Full Text View

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:

MedlinePlus related topics: Cancer Quitting Smoking Smoking

U.S. FDA Resources

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 2012
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

subjects will receive either internet or telephone counseling

telephone or internet counseling

internet based counseling

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Amanda L. Graham, PhD

Lombardi Cancer Research Center

More Information

Additional Information:

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

Publications:

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Graham AL, Papandonatos GD, Kang H, Moreno JL, Abrams DB. Development and validation of the online social support for smokers scale. J Med Internet Res. 2011 Sep 28;13(3):e69.

Graham AL, Cobb NK, Papandonatos GD, Moreno JL, Kang H, Tinkelman DG, Bock BC, Niaura RS, Abrams DB. A randomized trial of Internet and telephone treatment for smoking cessation. Arch Intern Med. 2011 Jan 10;171(1):46-53.

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.

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:	April 3, 2012
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 May 23, 2013