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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02698 | Registry Identifier | NCI CTRP |
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No activties have occurred and no participants have enrolled in this protocol
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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.
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):
Study Groups:
If participant is in Group 1 (ST):
If participant is in Group 2 (HALT):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Project HALT II: In-Depth Interviews | Experimental | Participants complete a computerized questionnaire to assess demographics and smoking history. Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. |
|
| Project HALT II: Standard Treatment (ST) | Active Comparator | Participants complete a computerized questionnaire to assess demographics and smoking history at baseline. Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up. Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline. Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. |
|
| Project HALT II: Tailored Treatment (HALT) | Experimental | Participants complete a computerized questionnaire to assess demographics and smoking history at baseline. Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up. Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions. Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Participants complete a computerized questionnaire to assess demographics and smoking history. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Helping Adults with Health Literacy Trouble (HALT) versus Standard Treatment (ST) in Facilitating Abstinence from Smoking in Low Health Literacy (HL) Smokers | Efficacy defined as the proportion of participants who successfully quit smoking. | 3 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana S. Hoover, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Literacy Advance of Houston | Houston | Texas | 77042 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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|
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| In-Depth Interviews | Behavioral | Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. The interview should last 30-45 minutes and is audio-recorded. |
|
| Breath Test | Other | Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up. |
|
| Nicotine Patches | Drug | Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Patch therapy for participants who smoke >10 cigarettes/day consists of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. |
|
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| Advice plus Phone Counseling | Behavioral | Participants receive brief advice to quit smoking, as well as phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline. |
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| Advice plus Counseling Sessions | Behavioral | Participants receive brief advice to quit smoking, as well as 5 individual, in-person smoking cessation treatment counseling sessions. |
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| Self Assessment Questionnaires | Behavioral | Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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