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Smoking Cessation for Low-Income Adults

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ClinicalTrials.gov Identifier: NCT00948129
Recruitment Status : Active, not recruiting
First Posted : July 29, 2009
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Smoking Cessation Smoking Behavioral: Smoking cessation training, support, and telephone follow-up Behavioral: Smoking cessation intervention Behavioral: Weekly Telephone Coaching

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Cancer Outreach for Low-income Adults With Innovative Smoking Cessation
Actual Study Start Date : June 2010
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Smoking Abstinence Rates [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948129


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Alex Prokhorov, MD, PHD M.D. Anderson Cancer Center

Additional Information:
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 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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