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Internet and Telephone Counseling for Smoking Cessation


N/A
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Internet and Telephone Counseling for Smoking Cessation


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Amanda L. Graham, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000465179

NCT ID:

NCT00282009

Start Date:

August 2004

Completion Date:

December 2014

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Brown University School of Medicine Providence, Rhode Island  02905