Health Literacy and Smoking Cessation in Low-SES Diverse Smokers - Project HALT II
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 11/30/2018 |
| Start Date: | January 2019 |
| End Date: | December 31, 2019 |
| Contact: | Diana S. Hoover, PHD |
| Email: | CR_Study_Registration@mdanderson.org |
| Phone: | 713-563-7564 |
In-Depth Interviews:
The goal of this research study is to learn about ways to help people might have trouble
understanding health information quit smoking.
Pilot Study:
The goal of this research study is to test 2 different approaches, Standard Treatment (ST)
and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping
smokers who might have trouble understanding health information with quitting smoking.
The goal of this research study is to learn about ways to help people might have trouble
understanding health information quit smoking.
Pilot Study:
The goal of this research study is to test 2 different approaches, Standard Treatment (ST)
and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping
smokers who might have trouble understanding health information with quitting smoking.
In-Depth Interviews:
Study Visit:
If participant is eligible and agrees to take part, the following will occur at their visit:
Questionnaire:
Participant will complete a questionnaire on a computer that will include questions about
their thoughts about smoking, their smoking history, their ability to understand health
information, and basic questions about their age, education, and income. This may take up to
45 minutes to complete.
Individual In-Depth Interviews:
After completing the questionnaire, participant will take part in an individual, in-depth
interview. As part of the interview, the study chair will ask participant about their
smoking, any previous attempts at quitting, and what they would like to see included as part
of a program to help smokers like them with quitting smoking.
The interview should last 30-45 minutes and will be audio-recorded. No identifying
information will be included in recorded interviews (participant's name will not be used).
Recordings will be transcribed (written down). Audio recordings will be permanently deleted
within a year after the completion of data collection.
Length of Study Participation:
It may take up to 2 hours to complete this visit. Participation in this study will be over
after participant completes the interview.
Pilot Study:
Baseline Visit:
If participant is eligible and agrees to take part in this study, the following will occur
when they start the study (also called a baseline visit):
- Participant will complete a questionnaire on the computer that will include questions
about their feelings, mood, health, thoughts about smoking, thoughts about quitting
smoking, and their smoking history. It will also include questions about participant's
age, education, and income. This may take up to 1 hour to complete.
- Participant will complete a breath test to help the research team learn about the amount
of cigarette smoke they inhale. The breath test uses a disposable cardboard tube
attached to a machine, and participant will be asked to blow a long, slow, steady breath
into it.
- Participant will then be randomly assigned (as in the flip of a coin) into 1 of 2 study
groups (explained below). This is done because no one knows if one study group is
better, the same, or worse than the other group. There is an equal chance of being
assigned to either group.
Study Groups:
If participant is in Group 1 (ST):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to
use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive phone counseling for support in quitting smoking (5 sessions
over the course of 6 weeks) with a counselor at the Texas Quitline, an organization that
helps people quit smoking. Counseling is designed to help participant to improve their
problem-solving and coping skills, and plan for quitting smoking. Calls are expected to
last up to 45 minutes.
If participant is in Group 2 (HALT):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to
use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive 5 individual, in-person counseling sessions for support in
quitting smoking. Sessions are designed to help participant to improve their
problem-solving and coping skills, overcome barriers to quitting smoking, and plan for
quitting smoking. These sessions will take place at either of Literacy Advance's 2 main
campuses over 6 weeks. Participant will attend sessions the week before they quit
smoking, on the day that they quit, and 1, 2, and 4 weeks after quitting. Each of these
sessions will last about 45 minutes.
Weekly In-Person Visits (Groups 1 and 2):
Participant will complete questionnaires in person and at Literacy Advance over 6 weeks (the
week before they quit smoking, on the day that they quit, and 1, 2, and 4 weeks after
quitting). These questionnaires will ask about participant's current smoking, motivation to
quit smoking, confidence for quitting, stress, and emotions/mood. Participant will also
complete a breath test to help researchers learn about the amount of cigarette smoke
participant inhales. This should take about 30 minutes to complete.
3-Month In-Person Follow-Up Visit (Groups 1 and 2): Eight (8) weeks after the last counseling
session (or 3 months after beginning the study), participant will attend an in-person,
follow-up visit in which they will complete questionnaires and a breath test to help the
researchers learn about the amount of cigarette smoke participant inhales. This should take
about 30 minutes to complete.
Length of Study:
If participant does not quit smoking on their "Quit Day" (Week 0), they may continue
participating in the study and may select another "Quit Day."
Participant will take part in the study for up to 3 months. Participation will be over when
participant completes the study visit at Month 3.
This is an investigational study. The nicotine patch is FDA approved and commercially
available.
Up to 50 participants will take part in this pilot study. Up to 80 participants overall will
take part in this study. All will be enrolled at MD Anderson.
Study Visit:
If participant is eligible and agrees to take part, the following will occur at their visit:
Questionnaire:
Participant will complete a questionnaire on a computer that will include questions about
their thoughts about smoking, their smoking history, their ability to understand health
information, and basic questions about their age, education, and income. This may take up to
45 minutes to complete.
Individual In-Depth Interviews:
After completing the questionnaire, participant will take part in an individual, in-depth
interview. As part of the interview, the study chair will ask participant about their
smoking, any previous attempts at quitting, and what they would like to see included as part
of a program to help smokers like them with quitting smoking.
The interview should last 30-45 minutes and will be audio-recorded. No identifying
information will be included in recorded interviews (participant's name will not be used).
Recordings will be transcribed (written down). Audio recordings will be permanently deleted
within a year after the completion of data collection.
Length of Study Participation:
It may take up to 2 hours to complete this visit. Participation in this study will be over
after participant completes the interview.
Pilot Study:
Baseline Visit:
If participant is eligible and agrees to take part in this study, the following will occur
when they start the study (also called a baseline visit):
- Participant will complete a questionnaire on the computer that will include questions
about their feelings, mood, health, thoughts about smoking, thoughts about quitting
smoking, and their smoking history. It will also include questions about participant's
age, education, and income. This may take up to 1 hour to complete.
- Participant will complete a breath test to help the research team learn about the amount
of cigarette smoke they inhale. The breath test uses a disposable cardboard tube
attached to a machine, and participant will be asked to blow a long, slow, steady breath
into it.
- Participant will then be randomly assigned (as in the flip of a coin) into 1 of 2 study
groups (explained below). This is done because no one knows if one study group is
better, the same, or worse than the other group. There is an equal chance of being
assigned to either group.
Study Groups:
If participant is in Group 1 (ST):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to
use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive phone counseling for support in quitting smoking (5 sessions
over the course of 6 weeks) with a counselor at the Texas Quitline, an organization that
helps people quit smoking. Counseling is designed to help participant to improve their
problem-solving and coping skills, and plan for quitting smoking. Calls are expected to
last up to 45 minutes.
If participant is in Group 2 (HALT):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to
use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive 5 individual, in-person counseling sessions for support in
quitting smoking. Sessions are designed to help participant to improve their
problem-solving and coping skills, overcome barriers to quitting smoking, and plan for
quitting smoking. These sessions will take place at either of Literacy Advance's 2 main
campuses over 6 weeks. Participant will attend sessions the week before they quit
smoking, on the day that they quit, and 1, 2, and 4 weeks after quitting. Each of these
sessions will last about 45 minutes.
Weekly In-Person Visits (Groups 1 and 2):
Participant will complete questionnaires in person and at Literacy Advance over 6 weeks (the
week before they quit smoking, on the day that they quit, and 1, 2, and 4 weeks after
quitting). These questionnaires will ask about participant's current smoking, motivation to
quit smoking, confidence for quitting, stress, and emotions/mood. Participant will also
complete a breath test to help researchers learn about the amount of cigarette smoke
participant inhales. This should take about 30 minutes to complete.
3-Month In-Person Follow-Up Visit (Groups 1 and 2): Eight (8) weeks after the last counseling
session (or 3 months after beginning the study), participant will attend an in-person,
follow-up visit in which they will complete questionnaires and a breath test to help the
researchers learn about the amount of cigarette smoke participant inhales. This should take
about 30 minutes to complete.
Length of Study:
If participant does not quit smoking on their "Quit Day" (Week 0), they may continue
participating in the study and may select another "Quit Day."
Participant will take part in the study for up to 3 months. Participation will be over when
participant completes the study visit at Month 3.
This is an investigational study. The nicotine patch is FDA approved and commercially
available.
Up to 50 participants will take part in this pilot study. Up to 80 participants overall will
take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. (IN-DEPTH INTERVIEWS - INCLUSION CRITERIA; 2-6)
2. Age 25-65 years
3. Current smoker (>/= 5 cigarettes/day for the last year)
4. Limited or marginal HL (total score
5. Have a home address where information can be mailed and a working telephone
6. English speaker
7. Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
8. (PILOT STUDY - INCLUSION CRITERIA; 8-13)
9. Age 25-65 years
10. Current smoker (>/= 5 cigarettes/day for the last year; biochemically verified with
expired carbon monoxide (CO) reading of >/=8 parts per million [ppm])
11. Limited or marginal HL (total score
12. Motivated to quit smoking within the next 30 days
13. Have a home address where information can be mailed and a working telephone
14. English speaker
15. Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
Exclusion Criteria:
1. (IN-DEPTH INTERVIEWS - EXCLUSION CRITERIA; 2-5)
2. Regular use of tobacco products other than cigarettes
3. Current use of tobacco cessation medications
4. Pregnancy or lactation
5. Enrolled in another smoking cessation study/program
6. (PILOT STUDY - EXCLUSION CRITERIA; 7-12)
7. Contraindication for nicotine patch
8. Regular use of tobacco products other than cigarettes
9. Current use of tobacco cessation medications
10. Pregnancy or lactation
11. A household member is enrolled in the study
12. Enrolled in another smoking cessation study/program
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