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

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

Interventions

BEHAVIORAL

Questionnaire

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

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.

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.

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

Advice plus Counseling Sessions

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

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Diana S. Hoover, PHD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-14

Primary Completion

2018-12-14

Completion

2018-12-14

FDA Drug

Yes

Countries

• United States

Study Locations