Reducing Cancer Disparities Among Latinos in Texas
3 other identifiers
interventional
301
1 country
2
Brief Summary
The goal of this research study is to learn if a wellness program can help improve diet and physical activity levels and encourage smoking cessation in Latino individuals who are overweight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2022
CompletedMay 31, 2022
May 1, 2022
10.1 years
January 3, 2012
May 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction
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.
6 months
Study Arms (2)
Health Education (HE)
EXPERIMENTALHE 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.
Motivation and Problem Solving (MAPS)
EXPERIMENTALHE 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.
Interventions
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).
Computer-based questionnaires completed at baseline, then every 6 months taking 60-90 minutes to complete.
9 proactive, telephone counseling sessions over 18 months. Each of these phone calls should last about 20-30 minutes.
6-week supply of nicotine patches given to participants ready to quit smoking.
Eligibility Criteria
You may qualify if:
- Latino adults
- years of age or older
- Current smoker with a history of smoking an average of at least 1 cigarette per day during the last year
- Overweight/obese (BMI greater than or equal to 25)
- Functioning telephone number
- Valid home address
- Ability to engage in low to moderate physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
- 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.
- Can speak, read, and understand Spanish and/or English
You may not qualify if:
- Pregnancy or lactation
- Participants who were recruited for the pilot and focus groups are not eligible for the randomized trial.
- Contraindication for nicotine patch use
- Regular use of tobacco products
- Current use of tobacco cessation medications
- Currently enrolled in another smoking cessation study
- Another household member enrolled in the study
- Scores below 38 on the Short Assessment of Health Literacy for Spanish Adults (SAHLSA)
- Active substance abuse or dependence
- Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
William Marsh Rice University
Houston, Texas, 77005, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Castro Y, Basen-Engquist K, Fernandez ME, Strong LL, Eakin EG, Resnicow K, Li Y, Wetter DW. Design of a randomized controlled trial for multiple cancer risk behaviors among Spanish-speaking Mexican-origin smokers. BMC Public Health. 2013 Mar 18;13:237. doi: 10.1186/1471-2458-13-237.
PMID: 23506397DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Basen-Engquist, PHD, BA, MPH
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 6, 2012
Study Start
January 1, 2012
Primary Completion
January 18, 2022
Study Completion
January 18, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05