NCT01352000

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,830

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

7.8 years

First QC Date

May 10, 2011

Last Update Submit

February 21, 2017

Conditions

Smoking Cessation

Keywords

self helpsmoking cessationcancer prevention

Outcome Measures

Primary Outcomes (1)

  • 7-Day Point-Prevalence Abstinence at Each Follow-up Point

    To test the effectiveness of a self-help, relapse-prevention intervention (Forever Free booklets) as an adjunct to a state telephone quitline

    24 months

Study Arms (3)

Usual Care (UC)

ACTIVE COMPARATOR

Receive Quitline services

Behavioral: Smoking Cessation

Repeated Mailings (RM)

ACTIVE COMPARATOR

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

Behavioral: Smoking Cessation

Massed Mailings (MM)

ACTIVE COMPARATOR

Receive all 8 booklets in a single mailing

Behavioral: Smoking Cessation

Interventions

Smoking CessationBEHAVIORAL

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

Also known as: Quitline, NYSSQL, relapse-prevention, Forever Free
Massed Mailings (MM)Repeated Mailings (RM)Usual Care (UC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referrals from the New York State Smokers' Quitline
  • at least 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Thomas Brandon, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 11, 2011

Study Start

December 1, 2008

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)