Internet and Telephone Counseling for Smoking Cessation

NCT ID: NCT00282009

Last Updated: 2016-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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 QuitNetâ„¢ 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 QuitNetâ„¢ website including interactive and individualized intervention features.
* Arm III (premium internet program plus telephone counseling): Patients receive free access to the QuitNetâ„¢ 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.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Basic Internet

Basic Internet

Group Type ACTIVE_COMPARATOR

Basic Internet

Intervention Type BEHAVIORAL

Basic Internet control intervention

Enhanced Internet

Enhanced Internet

Group Type EXPERIMENTAL

Enhanced Internet

Intervention Type BEHAVIORAL

enhanced Internet cessation intervention

Enhanced Internet plus Phone

Enhanced Internet + proactive telephone counseling

Group Type EXPERIMENTAL

Enhanced Internet + phone

Intervention Type BEHAVIORAL

enhanced Internet plus proactive telephone counseling

Interventions

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Basic Internet

Basic Internet control intervention

Intervention Type BEHAVIORAL

Enhanced Internet

enhanced Internet cessation intervention

Intervention Type BEHAVIORAL

Enhanced Internet + phone

enhanced Internet plus proactive telephone counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda L. Graham, PhD

Role: PRINCIPAL_INVESTIGATOR

Lombardi Comprehensive Cancer Center

Locations

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Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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(Suppl 1):S43-8. doi: 10.1080/14622200601042521.

Reference Type BACKGROUND
PMID: 17491170 (View on PubMed)

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(Suppl 1):S49-57. doi: 10.1080/14622200601045367.

Reference Type RESULT
PMID: 17491171 (View on PubMed)

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. doi: 10.2196/jmir.987.

Reference Type RESULT
PMID: 18364345 (View on PubMed)

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. doi: 10.1001/archinternmed.2010.451.

Reference Type RESULT
PMID: 21220660 (View on PubMed)

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. doi: 10.2196/jmir.1801.

Reference Type RESULT
PMID: 21955465 (View on PubMed)

Graham AL, Chang Y, Fang Y, Cobb NK, Tinkelman DS, Niaura RS, Abrams DB, Mandelblatt JS. Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study. Tob Control. 2013 Nov;22(6):e11. doi: 10.1136/tobaccocontrol-2012-050465. Epub 2012 Sep 25.

Reference Type RESULT
PMID: 23010696 (View on PubMed)

Cobb CO, Niaura RS, Donaldson EA, Graham AL. Quit now? Quit soon? Quit when you're ready? Insights about target quit dates for smoking cessation from an online quit date tool. J Med Internet Res. 2014 Feb 17;16(2):e55. doi: 10.2196/jmir.3086.

Reference Type RESULT
PMID: 24534139 (View on PubMed)

Cobb CO, Graham AL. Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation. Nicotine Tob Res. 2014 Oct;16(10):1289-97. doi: 10.1093/ntr/ntu066. Epub 2014 May 8.

Reference Type RESULT
PMID: 24812022 (View on PubMed)

Graham AL, Papandonatos GD, Cobb CO, Cobb NK, Niaura RS, Abrams DB, Tinkelman DG. Internet and Telephone Treatment for smoking cessation: mediators and moderators of short-term abstinence. Nicotine Tob Res. 2015 Mar;17(3):299-308. doi: 10.1093/ntr/ntu144. Epub 2014 Aug 25.

Reference Type RESULT
PMID: 25156528 (View on PubMed)

Graham AL, Papandonatos GD, Erar B, Stanton CA. Use of an online smoking cessation community promotes abstinence: Results of propensity score weighting. Health Psychol. 2015 Dec;34S(0):1286-95. doi: 10.1037/hea0000278.

Reference Type RESULT
PMID: 26651470 (View on PubMed)

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type DERIVED
PMID: 39868569 (View on PubMed)

Other Identifiers

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R01CA104836

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000465179

Identifier Type: -

Identifier Source: org_study_id

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