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.

  Hide Detailed Description

Detailed Description:

Researchers want to learn if telephone counseling can help smokers change their smoking patterns, when combined with other interventions.

Study Groups:

During the first (baseline) visit, you will be randomly assigned (as in a throw of the dice) to 1 of 6 possible study groups. The first group will receive free self-help materials, and a referral to the Quitline. The Quitline provides free quit smoking services to eligible callers. The second group will receive free self-help materials, a referral to the Quitline, and 300 pieces of nicotine gum at baseline. The third group will receive free self-help materials, a referral to the Quitline, and 6 telephone counseling sessions over the next 2 years. The fourth group will receive free self-help materials, a referral to the Quitline, 6 telephone counseling sessions over the next 2 years, and 300 pieces of nicotine gum at baseline. The fifth group will receive free self-help materials, a referral to the Quitline, and 12 telephone counseling sessions over the next 2 years. Finally, the sixth group will receive free self-help materials, a referral to the Quitline, 12 telephone counseling sessions over the next 2 years, and 300 pieces of nicotine gum at baseline. All participants, regardless of assigned group, will also receive up to 600 pieces of nicotine gum upon request when they are ready to try to quit smoking. This is in addition to the 300 pieces of gum some participants will receive at the baseline visit.

Study Visits:

If you choose to take part in this study, you will visit M. D. Anderson up to 5 times. Your first visit is the "baseline" visit when you enter the study. You will then be asked to come back for 4 follow-up visits at 6, 12, 18, and 24 months after enrolling in the study.

Study Tests:

The following tests and procedures will be performed at the study visits:

  • You will be asked to complete some questionnaires that will include questions about your feelings, moods, and smoking status. These will take 60 to 90 minutes to complete.
  • You will have your height, weight, and waistline measured.
  • You will complete a breath test to help estimate (guess) the amount of cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is attached to the machine, and you blow a long, slow, steady breath into it.
  • At the baseline visit and the 24-month visit only, you will have saliva samples collected for cotinine tests. To collect the saliva, you will be asked to put a small piece of cotton in your mouth for a few minutes. These samples will be used to measure the amount of cotinine in your saliva. Cotinine is a chemical released in your body when it breaks down nicotine.

All participants will be contacted by mail or telephone throughout the length of the study. You may be contacted by mail, telephone, and/or e-mail during the study and follow-up, to be given reminders of clinic visits. You will be asked to provide the names and contact information for family and/or friends for the study staff to contact if the study staff has trouble reaching you.

Genetic Testing:

As part of this study, you will be asked to provide a saliva sample that will be collected at the first visit. To collect the saliva sample, you will be spitting into a container. Researchers will perform genetic tests with these samples to look for genes that control the production and use of neurotransmitters, naturally occurring chemical messengers in the brain. People with certain genes may have a more difficult time quitting smoking, because of the way nicotine affects these chemicals. The saliva sample will be stored in a biorepository at M. D. Anderson for use in future research related to nicotine addiction, smoking, and/or cancer.

Your saliva sample will be placed in a bank of biological samples and data that is available to researchers conducting research related to cancer or nicotine dependence.

Before your saliva sample can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of M. D. Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at M. D. Anderson, including research involving your saliva sample from this bank, must first be approved by the IRB.

Your samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. Other researchers using your samples will not be able to link this data to you.

Genetic information obtained will not be provided to you.

Telephone Counseling:

The telephone counseling sessions will be digitally recorded. The recordings, if not destroyed, may be kept for use in future research studies. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and may be used in the future to help the investigators better understand or improve the counseling treatment. No one but the study investigators and their staff will be allowed to view or listen to the recordings, and the identity of the participants will be kept strictly confidential. Your study identification number will be stated by the counselor at the beginning of the taped session. The recordings are stored digitally, encrypted, and password protected.

This is an investigational study. The nicotine gum used in this study is approved by the FDA. Up to 1000 smokers will take part in this research study. All will be enrolled at M. D. Anderson.

  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:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014