Smoking Cessation for Low-Income Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 8, 2014
Last verified: September 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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948129

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

Locations
United States, Texas
University of Texas 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 M.D. 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: September 8, 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

ClinicalTrials.gov processed this record on September 16, 2014