Smoking Cessation for Low-Income Adults

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00948129
First received: July 14, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The goal of this study is to learn which of 3 methods is best for helping people quit smoking.

Objectives:

Specific Aim 1: Specific Aim 1: Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial. The interventions will include a Standard Care (SC) approach, consisting of brief advice to quit smoking, nicotine replace therapy (NRT), and self-help written materials; an Enhanced Care (EC) approach, consisting of the standard care components and a cell phone-delivered text/graphical messaging component; and an Intensive Care (IC) approach, consisting of all SC and EC components plus a series of 11 cell phone-delivered proactive counseling sessions and a cell phone-delivered text/graphical messaging component.

Hypothesis 1.1. Participants randomized to the EC condition will have higher smoking abstinence rates at 12-month follow-up compared to participants randomized to the SC condition.

Hypothesis 1.2. Participants randomized to the IC condition will have higher smoking abstinence rates at 12-month follow-up compared to participants randomized to the EC condition.

Specific Aim 2: Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence

Hypothesis 2.1: The EC's and IC's effects on abstinence will be mediated by quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect.

Specific Aim 3: Compare the cost-effectiveness of the three treatment conditions.

Hypothesis 3.1: Compared to SC and EC, the IC is a cost-effective use of health care resources.


Condition Intervention
Smoking Cessation
Smoking
Behavioral: Smoking cessation training, support, and telephone follow-up
Behavioral: Smoking cessation intervention
Behavioral: Weekly Telephone Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancing Cancer Outreach for Low-income Adults With Innovative Smoking Cessation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Smoking Abstinence Rates [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 756
Study Start Date: June 2010
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Care
Group 1 - Standard Care (SC) approach
Behavioral: Smoking cessation training, support, and telephone follow-up
Brief coach advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials
Experimental: Enhanced Care
Group 2 - Enhanced Care (EC) approach
Behavioral: Smoking cessation training, support, and telephone follow-up
Brief coach advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials
Behavioral: Smoking cessation intervention
SC components plus a single motivational interviewing counseling session and a cell phone-delivered text/graphical messaging component
Experimental: Intensive Care
Group 3 - Intensive Care (IC) approach
Behavioral: Smoking cessation training, support, and telephone follow-up
Brief coach advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials
Behavioral: Smoking cessation intervention
SC components plus a single motivational interviewing counseling session and a cell phone-delivered text/graphical messaging component
Behavioral: Weekly Telephone Coaching
SC and EC components plus a series of 11 cell phone-delivered proactive counseling sessions and a cell phone-delivered text/graphical messaging component

  Hide Detailed Description

Detailed Description:

Baseline Interview:

If you are found to be eligible to take part in this study, you will complete a series of questionnaires on a laptop computer. You will be asked questions about your smoking habits. You will be asked how much tobacco you use, how many times you have tried to quit, how ready you are to quit, and how dependent you are on nicotine. You will be asked about symptoms related to nicotine withdrawal and any breathing problems associated with smoking. You will also be asked about support you receive from family and friends. The questionnaires on the laptop will take about 1 hour to complete. You will also complete an interview with the study staff to test your level of basic health knowledge. This test will about 10 minutes to complete.

Study Groups:

You will be assigned to a study group based on the location of where you enroll in the study. Everybody enrolled at a location will be in the same group and will get the same help.

Study Procedures:

For participants in Group 1:

  • You will receive a cell phone for study staff to call you about scheduled follow-up visits.
  • Right after the baseline interview, you will be asked by the study staff to set a quit date. The study staff will explain why it is important for you to quit and will also explain how to use the nicotine patches you will receive.
  • You will receive a manual that explains how important it is to quit smoking, how smoking hurts your health, and how family and friends can help while you try to quit. You will receive this manual at the beginning of the study.
  • You will receive a 10-week supply of nicotine patches that may help you to quit.

In addition to everything Group 1 receives, for participants in Groups 2 and 3:

  • You will receive a telephone number to a hotline for you to use to call and talk to someone who can help you to quit. You can use the cell phone you are given to call the hotline anytime you need support in your effort to quit smoking or stay quit.
  • You will receive between 1-5 supportive text messages a day on the cell phone. These text messages will continue for 12 weeks.
  • Once per week, you will receive a text message from the study staff asking if you have smoked within the past 24 hours. You will be asked to respond to this text message either by sending a text back to the study staff or calling the hotline. If the study staff does not receive your response you may receive a phone call from the staff asking about your smoking status over the past 24 hours.

If you are in Group 3, you will also receive 11 phone calls over a 12-week period. During this call, you will be given support to help you quit and stay quit, and each call will last about 15 minutes. These phone calls will be recorded, and the recordings may be used by the study staff to check the quality of the support you receive.

Follow-Up:

Study staff will call you once per month for 6 months to ask you for information about how you are doing with quitting smoking.

A year after you started the study, you will be asked to return to the site where you were enrolled in the study for an in-person follow-up interview. You will be asked for more information about quitting smoking and how the study went for you. At this visit, you will also be asked to spit into a clean cup and to blow into a cardboard tube to check your smoking levels. This session will last about 1 hour.

Length of Study:

You will be on study for about 1 year.

This is an investigational study.

Up to 756 participants will take part in this study. All will be enrolled at community sites in the greater-Houston area.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, 18 years of age or older
  2. Smoked at least 100 cigarettes in lifetime
  3. English or Spanish speaking
  4. Currently smoking at least 5 cigarettes a day, on average
  5. Willing to set a quit smoking date within a week of the enrollment

Exclusion Criteria:

  1. Positive history of a medical condition that precludes use of the nicotine patch
  2. Current use of nicotine replacement therapy (NRT)
  3. Current use of other smoking cessation medications (e.g., Chantix or Zyban)
  4. Pregnant or nursing
  5. Enrolled in another smoking cessation study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948129

Contacts
Contact: Alex Prokhorov, MD, PHD 20090336@mdanderson.org

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Alex Prokhorov, MD, PHD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Alex Prokhorov, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00948129     History of Changes
Other Study ID Numbers: 2009-0336, 1R01CA141628-01
Study First Received: July 14, 2009
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Smoking Cessation
Low-Income
Cigarette smoking
Uninsured and underinsured
NRT
Nicoderm CQ
Habits

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 23, 2014