Offering Proactive Tobacco Treatment

NCT ID: NCT01123967

Last Updated: 2015-05-27

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

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-08-31

Brief Summary

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This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).

Detailed Description

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Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).

Conditions

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Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRO+NRT+TC

Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC)

Group Type EXPERIMENTAL

proactive outreach (PRO)

Intervention Type OTHER

a mailed invitation letter followed by telephone outreach

telephone counseling (TC)

Intervention Type OTHER

free telephone counseling

Nicotine replacement therapy (NRT)

Intervention Type OTHER

free nicotine replacement therapy (NRT)

Usual Care (UC)

Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray

Group Type ACTIVE_COMPARATOR

Usual care (UC)

Intervention Type OTHER

nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

Interventions

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proactive outreach (PRO)

a mailed invitation letter followed by telephone outreach

Intervention Type OTHER

telephone counseling (TC)

free telephone counseling

Intervention Type OTHER

Nicotine replacement therapy (NRT)

free nicotine replacement therapy (NRT)

Intervention Type OTHER

Usual care (UC)

nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must complete the baseline survey
* Current self-reported cigarette smoker
* Has a valid home address
* An adequate proficiency in English to complete study surveys and participate in telephone counseling.

Exclusion Criteria

* adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Fu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Veterans Administration Hospital

Anne Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

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Steven Fu, M.D.

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.

Reference Type DERIVED
PMID: 32614201 (View on PubMed)

Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.

Reference Type DERIVED
PMID: 31363948 (View on PubMed)

Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.

Reference Type DERIVED
PMID: 26931362 (View on PubMed)

Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.

Reference Type DERIVED
PMID: 24716466 (View on PubMed)

Other Identifiers

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0909S72235

Identifier Type: OTHER

Identifier Source: secondary_id

1R01CA141527

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009NTLS064

Identifier Type: -

Identifier Source: org_study_id

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