Community Network Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01504919
First received: January 3, 2012
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

Objectives:

The specific aims are to:

  1. Evaluate the efficacy of a Motivation and Problem Solving (MAPS) approach to promoting and facilitating cancer risk reduction among high-risk Latino individuals (overweight/obese smokers). Relative to Health Education, MAPS is hypothesized to result in positive changes in each of the primary smoking, diet, and physical activity outcomes.
  2. Assess the effects of MAPS on hypothesized treatment mechanisms (e.g., motivation, agency/self-efficacy, stress/affect) and the role of those mechanisms in mediating the effect of MAPS on outcomes.

Condition Intervention
Psychosocial Problem
Behavioral: Health Education
Behavioral: Questionnaires
Behavioral: Telephone Counseling Sessions
Drug: Nicotine Patches

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Reducing Cancer Disparities Among Latinos in Texas

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Generalized linear mixed model regression (GLMM) used in analyzing the effects of motivation and problem solving (MAPS) on the primary outcomes across the 6, 12, and 18-month time points.


Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health Education (HE)
HE of brief counseling and self-help materials addressing 3 risk behaviors, referrals to available resources, and a home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed.
Behavioral: Health Education
Brief counseling at baseline, at 6 months and again at 12 months, and self-help materials addressing smoking cessation, diet, physical activity, referrals to available resources, and a home-based exercise kit (e.g., pedometer, exercise ball, strength training cables).
Behavioral: Questionnaires
Computer-based questionnaires completed at baseline, then every 6 months taking 60-90 minutes to complete.
Other Name: surveys
Drug: Nicotine Patches
6-week supply of nicotine patches given to participants ready to quit smoking.
Experimental: Motivation and Problem Solving (MAPS)
HE counseling, self-help materials, and resource referrals, and home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. Plus 9 proactive, telephone counseling sessions over the 18 month period.
Behavioral: Health Education
Brief counseling at baseline, at 6 months and again at 12 months, and self-help materials addressing smoking cessation, diet, physical activity, referrals to available resources, and a home-based exercise kit (e.g., pedometer, exercise ball, strength training cables).
Behavioral: Questionnaires
Computer-based questionnaires completed at baseline, then every 6 months taking 60-90 minutes to complete.
Other Name: surveys
Behavioral: Telephone Counseling Sessions
9 proactive, telephone counseling sessions over 18 months. Each of these phone calls should last about 20-30 minutes.
Other Name: Counseling
Drug: Nicotine Patches
6-week supply of nicotine patches given to participants ready to quit smoking.

  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. Latino adults
  2. 18 years of age or older
  3. Current smoker with a history of smoking an average of at least 1 cigarette per day during the last year
  4. Overweight/obese (BMI greater than or equal to 25)
  5. Functioning telephone number
  6. Valid home address
  7. Ability to engage in low to moderate physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
  8. Blood Pressure readings <140/90 mm Hg as defined by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; Pressure readings >/=140/90 mm Hg will be deemed ineligible to participate and excluded from the study. They will be referred to their family physician or community services. Those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study.
  9. Can speak, read, and understand Spanish and/or English

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Participants who were recruited for the pilot and focus groups are not eligible for the randomized trial.
  3. Contraindication for nicotine patch use
  4. Regular use of tobacco products
  5. Current use of tobacco cessation medications
  6. Currently enrolled in another smoking cessation study
  7. Another household member enrolled in the study
  8. Scores below 38 on the Short Assessment of Health Literacy for Spanish Adults (SAHLSA)
  9. Active substance abuse or dependence
  10. Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
  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: NCT01504919

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David Wetter, PHD, MS, BA 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: NCT01504919     History of Changes
Other Study ID Numbers: 2010-0606, NCI-2012-00029, RFA-CA-0932
Study First Received: January 3, 2012
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Psychosocial
Behavioral intervention
Nicotine patch
Latinos
Mexican American
Motivation and Problem Solving
MAPS
Cancer risk reduction
Smoking cessation
Overweight/obese smokers
BMI greater than or equal to 25
Wellness program
Questionnaires
Surveys
Self-help materials
Pamphlets

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014