Internet and Telephone Counseling for Smoking Cessation

Georgetown University

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Behavioral: Basic Internet; Behavioral: Enhanced Internet; Behavioral: Enhanced Internet + phone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00282009

CDR0000465179

R01CA104836 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,205 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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2,205 participants in 3 patient groups

Basic Internet

Active Comparator group

Description:

Basic Internet

Treatment:

Behavioral: Basic Internet

Enhanced Internet

Experimental group

Description:

Enhanced Internet

Treatment:

Behavioral: Enhanced Internet

Enhanced Internet plus Phone

Experimental group

Description:

Enhanced Internet + proactive telephone counseling

Treatment:

Behavioral: Enhanced Internet + phone