Internet and Telephone Counseling for Smoking Cessation | NCT00282009

Studies
Internet and Telephone Counseling for Smoking Cessation

NCT00282009

Sponsor

Georgetown University

Status

Completed

Last Update Posted

Feb 10, 2016Estimated

Enrollment

2,205Actual

Phase

Not Applicable

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Basic Internet
Enhanced Internet
Enhanced Internet + phone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01CA104836	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 24, 2006

First Submission Date that Met QC Criteria

Jan 24, 2006

First Posted Date

Jan 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2016

Last Update Posted Date

Feb 10, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Basic Internet	Active Comparator	Basic Internet	Behavioral: Basic Internet
Enhanced Internet	Experimental	Enhanced Internet	Behavioral: Enhanced Internet
Enhanced Internet plus Phone	Experimental	Enhanced Internet + proactive telephone counseling	Behavioral: Enhanced Internet + phone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Basic Internet	Behavioral	Basic Internet control intervention	Basic Internet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amanda L. Graham, PhD	Lombardi Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University		Washington D.C.	District of Columbia	20007	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17491170	Background	Graham AL, Bock BC, Cobb NK, Niaura R, Abrams DB. Characteristics of smokers reached and recruited to an internet smoking cessation trial: a case of denominators. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S43-8. doi: 10.1080/14622200601042521.
17491171	Result	Graham AL, Papandonatos GD, Bock BC, Cobb NK, Baskin-Sommers A, Niaura R, Abrams DB. Internet- vs. telephone-administered questionnaires in a randomized trial of smoking cessation. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S49-57. doi: 10.1080/14622200601045367.