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OpenTrials
Completed

NCT Number: NCT00282009

Internet and Telephone Counseling for Smoking Cessation

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.

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Key information

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic Internet

Behavioral

Basic Internet control intervention

Enhanced Internet

Behavioral

enhanced Internet cessation intervention

Enhanced Internet + phone

Behavioral

enhanced Internet plus proactive telephone counseling

Primary outcomes

  1. Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Jan 25, 2006
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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