Reducing Tobacco Related Health Disparities
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00984724
First received: September 23, 2009
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
The goal of this research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.
Objectives:
The specific aims are to:
- Evaluate the efficacy of a Motivation And Problem Solving (MAPS) approach and proactive provision of nicotine replacement therapy (NRT) for promoting and facilitating cessation among smokers who are not ready to quit. Two versions of MAPS differing in the number of telephone sessions will be evaluated (MAPS-6; MAPS-12).
- Assess MAPS and NRT effects on hypothesized treatment mechanisms (e.g., motivation, intrinsic motives, stage of change, sense of control, self-efficacy, stress, negative affect, depression) and the role of those mechanisms in mediating MAPS effects on abstinence.
- Assess the cost-effectiveness of MAPS-6 and MAPS-12 and NRT.
- Collect and store extracted DNA for use in future research.
| Condition | Intervention |
|---|---|
|
Smoking Cessation Smoking |
Behavioral: Standard Treatment (ST) Behavioral: Telephone Counseling Behavioral: Quitline Behavioral: Nicotine Replacement Therapy (NRT) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Reducing Tobacco Related Health Disparities |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Patients with Tobacco Abstinence [ Time Frame: Assessments will occur at Baseline and at 6, 12, 18, and 24 months after Baseline. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Standard Treatment
Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Referral to Quitline.
|
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
|
|
Experimental: MAPS-6
Standard Treatment (ST) plus 6 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period.
|
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling
MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period Letter referring participants to a Quitline providing quit smoking services.
|
|
Experimental: MAPS-12
Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline.
|
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling
MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period Letter referring participants to a Quitline providing quit smoking services.
|
|
Experimental: Standard Treatment + NRT
Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.
|
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Quitline
Letter referring participants to a Quitline providing quit smoking services.
Behavioral: Nicotine Replacement Therapy (NRT)
300 pieces of nicotine gum issued at baseline visit.
|
|
Experimental: MAPS-6 + NRT
Standard Treatment (ST) plus 6 proactive telephone counseling sessions; delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.
|
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling
MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period Letter referring participants to a Quitline providing quit smoking services.
Behavioral: Nicotine Replacement Therapy (NRT)
300 pieces of nicotine gum issued at baseline visit.
|
|
Experimental: MAPS-12 + NRT
Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.
|
Behavioral: Standard Treatment (ST)
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Behavioral: Telephone Counseling
MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period Letter referring participants to a Quitline providing quit smoking services.
Behavioral: Nicotine Replacement Therapy (NRT)
300 pieces of nicotine gum issued at baseline visit.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- HCHD Patient or is at or below 200% of the poverty guideline
- 18 years of age or older
- Current smoker
- History of at least one cigarette per day for the past year
- Not ready to quit in the next 30 days
- Valid home address
- Functioning telephone number
- Can speak, read, and understand English
- Register "5" or more on a carbon monoxide breath test
Exclusion Criteria:
- Other household members enrolled in this study
- Enrolled in any other smoking study during the past 90 days
- Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
- Regular use of tobacco products other than cigarettes
- Pregnancy or lactation
- Active substance dependence (exclusive of nicotine dependence)
- Use of bupropion or nicotine products
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984724
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | David Wetter, PhD, MS, BA | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00984724 History of Changes |
| Other Study ID Numbers: | 2009-0372, 1R01CA141613-01 |
| Study First Received: | September 23, 2009 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Smoking Motivation and Problem Solving MAPS |
Low Income Smokers HCHD community clinics Telephone-based counseling |
Additional relevant MeSH terms:
|
Smoking Habits Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013