Internet and Telephone Counseling for Smoking Cessation

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Behavioral: Basic Internet; Behavioral: Enhanced Internet + phone; Behavioral: Enhanced Internet

• Registration Number: NCT00282009
• Lead Sponsor: Georgetown University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Status Verified: 2014-08
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2205

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basic Internet	Basic Internet	Basic Internet
Enhanced Internet plus Phone	Enhanced Internet + phone	Enhanced Internet + proactive telephone counseling
Enhanced Internet	Enhanced Internet	Enhanced Internet

Primary Outcome Measures

Name	Time	Method
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment	12 months

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States