Telephone and Web-based Teen Tobacco Cessation in HMOs

NCT00311948 | Completed Phase 3 DMC

• 2 other identifiers: 5R01CA098685-021R01CA098685-01A2
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to look at both the clinicians' ability to reach out to the teen smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment.

Conditions

Tobacco Use

Keywords

Teen smokers; Quithelper; Tobacco; Tobacco Website; Website Intervention; Tobacco counseling; Tobacco abstinence

Outcome Measures

Primary Outcomes (2)

• Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.

  self report of smoking in last 30 days

  6 months and 12 months

• 12-month measure to determine long-term assessment

  Self report smoking or not smoking.

  12-months

Secondary Outcomes (7)

• A six-month assessment to determine short-term effects

  6 months

• Assess the prevalence of smoking on 25 or more days per month

  1 month

• Assess sustained abstinence (e.g., three and six months) at each follow-up,

  3 months and 6 months

• Assess change in stage of change

  6 months and 12 months

• Assess amount smoked, and use of other tobacco products (including smokeless tobacco) in the last week, 30 days, three months, and six months prior to the follow-up assessment.

  30 days, 6 months, 12 months

Study Arms (2)

Telephone counseling + interactive website

ACTIVE COMPARATOR

Teen has access to interactive website and receives tailored telephone counseling

Behavioral: Telephone counseling + interactive website = more abstinence

Control with interactive website

OTHER

Teen only has access to interactive website.

Behavioral: Behavioral: interactive website

Interventions

Telephone counseling + interactive website = more abstinence BEHAVIORAL

Telephone counseling + interactive website

Behavioral: interactive website BEHAVIORAL

Control with interactive website

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• both males and females
• smoking cigarettes at least four days a month
• some interest in quitting (will take all teen regardless of stage of readiness
• no evidence of treatment for depression, alcohol, or drugs in last year
• must consent
• have physician's approval for outreach to their panel
• have (or able to get) Internet access and phone access
• willingness to participate in study and follow-up procedures.

You may not qualify if:

• \<15 years old
• \>18 years old
• treated within 1 year for depression, alcohol, or drugs
• No internet access or phone access

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Free & Clear, Inc.

Seattle, Washington, 98104, United States

Location

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MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jack F Hollis, Ph.D.

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2006
• First Posted: April 6, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 28, 2012

Record last verified: 2006-09

Locations

US (3)