Design of a randomized controlled trial for multiple cancer risk behaviors among Spanish-speaking Mexican-origin smokers

Yessenia Castro is with the School of Social Work, The University of Texas at Austin, Austin, TX, USA -- Karen Basen-Engquist is with the Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, USA -- Maria E Fernandez is with the Division of Health Promotion and Behavioral Science, The University of Texas School of Public Health, Houston, TX, USA -- Larkin L Strong and David W Wetter are with the Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Research - Unit 1440, PO Box 301402, Houston, TX, 77230-1402, USA -- Elizabeth G Eakin is with the Cancer Prevention Research Centre, School of Population Health, The University of Queensland, Brisbane, QLD, Australia -- Ken Resnicow is with the Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA -- Yisheng Li ia with the Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USABackground:Smoking, poor diet, and physical inactivity account for as much as 60% of cancer risk. Latinos experience profound disparities in health behaviors, as well as the cancers associated with them. Currently, there is a dearth of controlled trials addressing these health behaviors among Latinos. Further, to the best of our knowledge, no studies address all three behaviors simultaneously, are culturally sensitive, and are guided by formative work with the target population. Latinos represent 14% of the U.S. population and are the fastest growing minority group in the country. Efforts to intervene on these important lifestyle factors among Latinos may accelerate the elimination of cancer-related health disparities. Methods/design: The proposed study will evaluate the efficacy of an evidence-based and theoretically-driven Motivation And Problem Solving (MAPS) intervention, adapted and culturally-tailored for reducing cancer risk related to smoking, poor diet, and physical inactivity among high-risk Mexican-origin smokers who are overweight/obese (n = 400). Participants will be randomly assigned to one of two groups: Health Education (HE) or MAPS (HE + up to 18 MAPS counseling calls over 18 months). Primary outcomes are smoking status, servings of fruits and vegetables, and both self-reported and objectively measured physical activity. Outcome assessments will occur at baseline, 6 months, 12 months, and 18 months. Discussion: The current study will contribute to a very limited evidence base on multiple risk factor intervention studies on Mexican-origin individuals and has the potential to inform both future research and practice related to reducing cancer risk disparities. An effective program targeting multiple cancer risk behaviors modeled after chronic care programs has the potential to make a large public health impact because of the dearth of evidence-based interventions for Latinos and the extended period of support that is provided in such a program. Trial registration National Institutes of Health Clinical Trials Registry # NCT01504919Social Workdwetter@mdanderson.or