Internet and Telephone Counseling for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00282009
First received: January 24, 2006
Last updated: February 9, 2016
Last verified: August 2014
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: Basic Internet
Behavioral: Enhanced Internet
Behavioral: Enhanced Internet + phone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Internet and Telephone Counseling for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 2205
Study Start Date: August 2004
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Basic Internet
Basic Internet
Behavioral: Basic Internet
Basic Internet control intervention
Experimental: Enhanced Internet
Enhanced Internet
Behavioral: Enhanced Internet
enhanced Internet cessation intervention
Experimental: Enhanced Internet plus Phone
Enhanced Internet + proactive telephone counseling
Behavioral: Enhanced Internet + phone
enhanced Internet plus proactive telephone counseling

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282009

Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amanda L. Graham, PhD Lombardi Cancer Research Center
  More Information

Publications:

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00282009     History of Changes
Other Study ID Numbers: CDR0000465179  R01CA104836 
Study First Received: January 24, 2006
Last Updated: February 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Georgetown University:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on August 30, 2016