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

NCT02942212 | Withdrawn Early Phase 1 FDA Drug

• 2 other identifiers: 2016-0267NCI-2018-02698
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Nicotine patch; Nicoderm Committed Quitters; CQ; Nicoderm CQ; Questionnaires; Surveys; Interviews; Breath tests

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Behavioral: Questionnaire; Behavioral: In-Depth Interviews

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.

Behavioral: Questionnaire; Other: Breath Test; Drug: Nicotine Patches; Behavioral: Advice plus Phone Counseling; Behavioral: Self Assessment Questionnaires

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.

Behavioral: Questionnaire; Other: Breath Test; Drug: Nicotine Patches; Behavioral: Advice plus Counseling Sessions; Behavioral: Self Assessment Questionnaires

Interventions

Questionnaire BEHAVIORAL

Participants complete a computerized questionnaire to assess demographics and smoking history.

Also known as: Survey

Project HALT II: In-Depth Interviews; Project HALT II: Standard Treatment (ST); Project HALT II: Tailored Treatment (HALT)

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.

Project HALT II: In-Depth Interviews

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.

Project HALT II: Standard Treatment (ST); Project HALT II: Tailored Treatment (HALT)

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.

Also known as: Nicoderm Committed Quitters (CQ), Nicoderm CQ

Project HALT II: Standard Treatment (ST); Project HALT II: Tailored Treatment (HALT)

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.

Project HALT II: Standard Treatment (ST)

Advice plus Counseling Sessions BEHAVIORAL

Participants receive brief advice to quit smoking, as well as 5 individual, in-person smoking cessation treatment counseling sessions.

Project HALT II: Tailored Treatment (HALT)

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.

Also known as: Surveys

Project HALT II: Standard Treatment (ST); Project HALT II: Tailored Treatment (HALT)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-65 years
• Current smoker (\>/= 5 cigarettes/day for the last year)
• Limited or marginal HL (total score \</=6 on the CHEW Questionnaire)
• Have a home address where information can be mailed and a working telephone
• English speaker
• Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
• Age 25-65 years
• Current smoker (\>/= 5 cigarettes/day for the last year; biochemically verified with expired carbon monoxide (CO) reading of \>/=8 parts per million \[ppm\])
• Limited or marginal HL (total score \</=6 on the CHEW Questionnaire)
• Motivated to quit smoking within the next 30 days
• Have a home address where information can be mailed and a working telephone
• English speaker
• Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston

You may not qualify if:

• Regular use of tobacco products other than cigarettes
• Current use of tobacco cessation medications
• Pregnancy or lactation
• Enrolled in another smoking cessation study/program
• Contraindication for nicotine patch
• Regular use of tobacco products other than cigarettes
• Current use of tobacco cessation medications
• Pregnancy or lactation
• A household member is enrolled in the study
• Enrolled in another smoking cessation study/program

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

Literacy Advance of Houston

Houston, Texas, 77042, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking Cessation

Interventions

Surveys and Questionnaires; Tobacco Use Cessation Devices; Nicotine; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Diana S. Hoover, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: December 14, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (1)