Offering Proactive Tobacco Treatment
This study is currently recruiting participants.
Verified November 2012 by Masonic Cancer Center, University of Minnesota
Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborator:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01123967
First received: May 12, 2010
Last updated: November 6, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Tobacco Use Cessation |
Other: proactive outreach (PRO) Other: Free telephone counseling (TC) Other: Nicotine replacement therapy (NRT) Other: Usual care (UC) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations |
Resource links provided by NLM:
Further study details as provided by Masonic Cancer Center, University of Minnesota:
Primary Outcome Measures:
- Results in Abstinence Rates [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers.
Secondary Outcome Measures:
- Results in Treatment Utilization [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers.
- Cost-Effectiveness of Program [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Determine the cost-effectiveness of PRO+NRT+TC compared with UC.
| Estimated Enrollment: | 2500 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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)
|
Other: proactive outreach (PRO)
a mailed invitation letter followed by telephone outreach
Other: Free telephone counseling (TC)
free telephone counseling (TC)
Other: Nicotine replacement therapy (NRT)
free nicotine replacement therapy (NRT)
|
|
Active Comparator: Usual Care (UC)
Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray
|
Other: Usual care (UC)
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)
|
Detailed Description:
Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123967
Contacts
| Contact: Steven Fu, MD | 612-467-2582 | fuxxx@umn.edu |
Locations
| United States, Minnesota | |
| Steven Fu, M.D. | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Steven S Fu, MD 612-467-1979 Steven.Fu@va.gov | |
| Contact: Anne M Joseph, MD 612-626-5112 amjoseph@umn.edu | |
| Principal Investigator: Steven Fu, MD | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
| Principal Investigator: | Steven Fu, M.D. | Veterans Administration Hospital |
| Principal Investigator: | Anne Joseph, MD | Masonic Cancer Center, University of Minnesota |
More Information
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01123967 History of Changes |
| Other Study ID Numbers: | 2009NTLS064, 0909S72235, 1R01CA141527 |
| Study First Received: | May 12, 2010 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
nicotine replacement therapy smoking cessation tobacco dependent |
Additional relevant MeSH terms:
|
Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013