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Cancer Control Research

Abstract

The objective of the proposed study is to develop and evaluate innovative health communication interventions aimed at colorectal cancer prevention in a population based sample of North Carolina residents. The goals of the intervention are to: 1) increase mean daily servings of fruits and vegetables consumed; 2) increase mean frequency and metabolic expenditure (METS) of regular physical activity: and 3) increase the percentage of participants who obtain recommended colorectal cancer screening tests. The study will test the effectiveness and cost-effectiveness of two different intervention approaches: Tailored Printed Communications (TPC) and Tailored Motivational Interviews (TMI). The TPC component will include development and provision of four individually tailored bulletins that focus on the main health behaviors targeted for intervention (increasing fruits and vegetables, physical Activity, and colorectal cancer screening). The TMI component will include conducting four telephone-based motivational interviews focused on improving the same behaviors. The target population will be a randomly recruited population-based sample of North Carolina residents from 33 counties; including an equal number of participants with and without a history of colon cancer. This study's recruitment will be from the same population-based sample that is participating in the North Carolina Colon Cancer Study (NCCCS). A total of approximately 800 people will be recruited to participate. The study will use a factorial research design to test the relative impact of each intervention. We will use a stratified random assignment method (stratification by case/control status and by race), to ensure balance among conditions. Participants will be randomly assigned to one of four conditions: TPC Intervention, TMI Intervention, COMBINED (TPC and TMI), and CONTROL (receives generic materials not related to study objectives). This design will allow testing of the main effects of each intervention component as well as possible interaction effects between the components. Data will be collected from study participants at baseline prior to the start of interventions, and at 12 month follow-up. Survey data will be collected by trained staff using telephone-administered surveys. Data from the NCCCS surveys, which include detailed dietary, physical activity, health, and screening questions, will also be compared at baseline. Blood samples will be collected at baseline as part of the NCCCS study, and at follow-up to measure biomarkers associated with fruit and vegetable consumption. Cost data for the development and delivery of each intervention will be systematically collected. Process data will measure receipt, recall, and acceptability of each intervention. Primary analyses will focus on change in the targeted behaviors comparing experimental and control groups. Separate analyses will evaluate changes among those who have had colon cancer compared to those without the disease. Differences in effects by characteristics such as race, gender, education, and income will also be explored. Cost effectiveness analysis will provide population-based estimates associated with delivering these interventions.