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Reducing Tobacco Related Health Disparities

2014-08-27 03:19:04 | BioPortfolio

Summary

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

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

The specific aims are to:

1. Evaluate the efficacy of a Motivation and Problem Solving (MAPS) approach to 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 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.

Description

Study Groups:

During the first (baseline) visit, you will be randomly assigned (as with the throw of dice) to 1 of 3 possible study groups. The first group will receive free self-help materials, free nicotine replacement therapy when they are ready to quit, and a referral to the Texas Quitline. The Texas Quitline provides free quit smoking services to eligible callers. The second group will receive those same materials, as well as be scheduled for 6 telephone counseling sessions over the next 2 years. The third group will receive all the same materials and 12 telephone counseling sessions over the next 2 years.

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 also be asked to provide 2 buccal (cheek cells) samples that will be collected at the first and second visits using mouthwash. You will swish some mouthwash around in your mouth and spit it into a container. Researchers will perform genetic tests with these samples to look for genes that control the production and use of certain neurotransmitters (the chemical "messengers" in the brain). People with certain genes may have a harder time quitting smoking, because of the way nicotine affects these chemicals. The buccal samples will be stored in the Behavioral Treatment Research Center freezer at M. D. Anderson Cancer Center until they are sent for genetic testing. Buccal samples will be thrown away after the testing.

The samples will be assigned a unique study number in order to keep your identity confidential. You will not receive the results of the genetic tests, because the importance of this information is not known.

Telephone Counseling:

Some of 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 patch 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Smoking Cessation

Intervention

Standard Treatment (ST), Telephone Counseling

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:04-0400

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