Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")

NCT ID: NCT01352000

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3830 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-10-31

Brief Summary

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The study primary purpose is smoking relapse prevention. This study is a collaboration between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt Cancer Center in Tampa, Florida, and those associated with the "New York State Smokers' Quitline" (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.

Detailed Description

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In this study, approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call. One-third will be randomized to a Usual Care (UC) condition, which will receive regular quitline services. One-third will be randomized to a Repeated Mailings (RM) condition, which will receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months. And one-third will be randomized to a Massed Mailings (MM) condition, which will receive all 8 booklets in a single mailing.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Care (UC)

Receive Quitline services

Group Type ACTIVE_COMPARATOR

Smoking Cessation

Intervention Type BEHAVIORAL

Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.

Repeated Mailings (RM)

Receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months

Group Type ACTIVE_COMPARATOR

Smoking Cessation

Intervention Type BEHAVIORAL

Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.

Massed Mailings (MM)

Receive all 8 booklets in a single mailing

Group Type ACTIVE_COMPARATOR

Smoking Cessation

Intervention Type BEHAVIORAL

Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.

Interventions

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Smoking Cessation

Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.

Intervention Type BEHAVIORAL

Other Intervention Names

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Quitline NYSSQL relapse-prevention Forever Free

Eligibility Criteria

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Inclusion Criteria

* referrals from the New York State Smokers' Quitline
* at least 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Brandon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-15725

Identifier Type: -

Identifier Source: org_study_id

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