Health Literacy and Smoking Cessation in Low-SES Diverse Smokers - Project HALT II

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.

Study Overview

• Status: Withdrawn
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Questionnaire; Behavioral: In-Depth Interviews; Other: Breath Test; Drug: Nicotine Patches; Behavioral: Advice plus Phone Counseling; Behavioral: Self Assessment Questionnaires; Behavioral: Advice plus Counseling Sessions

Detailed Description

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 Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Literacy Advance of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 </=6 on the CHEW Questionnaire)
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 </=6 on the CHEW Questionnaire)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Project HALT II: In-Depth Interviews; 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.	Behavioral: Questionnaire; Participants complete a computerized questionnaire to assess demographics and smoking history.; Other Names: Survey; Behavioral: In-Depth Interviews; 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.
Active Comparator: Project HALT II: Standard Treatment (ST); 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.	Behavioral: Questionnaire; Participants complete a computerized questionnaire to assess demographics and smoking history.; Other Names: Survey; Other: Breath Test; Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.; Drug: Nicotine Patches; 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.; Other Names: Nicoderm CQ; Nicoderm Committed Quitters (CQ); Behavioral: Advice plus Phone Counseling; 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.; Behavioral: Self Assessment Questionnaires; 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.; Other Names: Surveys
Experimental: Project HALT II: Tailored Treatment (HALT); 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.	Behavioral: Questionnaire; Participants complete a computerized questionnaire to assess demographics and smoking history.; Other Names: Survey; Other: Breath Test; Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.; Drug: Nicotine Patches; 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.; Other Names: Nicoderm CQ; Nicoderm Committed Quitters (CQ); Behavioral: Self Assessment Questionnaires; 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.; Other Names: Surveys; Behavioral: Advice plus Counseling Sessions; Participants receive brief advice to quit smoking, as well as 5 individual, in-person smoking cessation treatment counseling sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Diana S. Hoover, PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Smoking Cessation; Questionnaires; Surveys; Interviews; Nicotine patch; Nicoderm Committed Quitters; CQ; Nicoderm CQ; Breath tests
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2016-0267; NCI-2018-02698 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No