Reducing Tobacco Related Health Disparities

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00984724
First received: September 23, 2009
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The goal of this research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.

Objectives:

The specific aims are to:

  1. Evaluate the efficacy of a Motivation And Problem Solving (MAPS) approach and proactive provision of nicotine replacement therapy (NRT) for promoting and facilitating cessation among smokers who are not ready to quit. Two versions of MAPS differing in the number of telephone sessions will be evaluated (MAPS-6; MAPS-12).
  2. Assess MAPS and NRT effects on hypothesized treatment mechanisms (e.g., motivation, intrinsic motives, stage of change, sense of control, self-efficacy, stress, negative affect, depression) and the role of those mechanisms in mediating MAPS effects on abstinence.
  3. Assess the cost-effectiveness of MAPS-6 and MAPS-12 and NRT.
  4. Collect and store extracted DNA for use in future research.

Condition Intervention
Smoking Cessation
Smoking
Behavioral: Standard Treatment (ST)
Behavioral: Telephone Counseling
Behavioral: Quitline
Behavioral: Nicotine Replacement Therapy (NRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Reducing Tobacco Related Health Disparities

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Tobacco Abstinence [ Time Frame: Assessments will occur at Baseline and at 6, 12, 18, and 24 months after Baseline. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Treatment
Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Referral to Quitline.
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Experimental: MAPS-6
Standard Treatment (ST) plus 6 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period.
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling

MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period

MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period

Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Experimental: MAPS-12
Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline.
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling

MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period

MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period

Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Experimental: Standard Treatment + NRT
Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Behavioral: Nicotine Replacement Therapy (NRT)
300 pieces of nicotine gum issued at baseline visit.
Experimental: MAPS-6 + NRT
Standard Treatment (ST) plus 6 proactive telephone counseling sessions; delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling

MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period

MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period

Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Behavioral: Nicotine Replacement Therapy (NRT)
300 pieces of nicotine gum issued at baseline visit.
Experimental: MAPS-12 + NRT
Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling

MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period

MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period

Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Behavioral: Nicotine Replacement Therapy (NRT)
300 pieces of nicotine gum issued at baseline visit.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. HCHD Patient or is at or below 200% of the poverty guideline
  2. 18 years of age or older
  3. Current smoker
  4. History of at least one cigarette per day for the past year
  5. Not ready to quit in the next 30 days
  6. Valid home address
  7. Functioning telephone number
  8. Can speak, read, and understand English
  9. Register "5" or more on a carbon monoxide breath test

Exclusion Criteria:

  1. Other household members enrolled in this study
  2. Enrolled in any other smoking study during the past 90 days
  3. Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
  4. Regular use of tobacco products other than cigarettes
  5. Pregnancy or lactation
  6. Active substance dependence (exclusive of nicotine dependence)
  7. Use of bupropion or nicotine products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984724

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: David Wetter, PhD, MS, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00984724     History of Changes
Other Study ID Numbers: 2009-0372, 1R01CA141613-01, NCI-2011-00289
Study First Received: September 23, 2009
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Smoking
Motivation and Problem Solving
MAPS
Low Income Smokers
HCHD community clinics
Telephone-based counseling

Additional relevant MeSH terms:
Smoking
Habits
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 July 22, 2014