Intervention Mediators in a Randomized Controlled Trial to Increase Colonoscopy Uptake Among Individuals at Increased Risk of Familial Colorectal Cancer
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Understanding the pathways by which interventions achieve behavioral change is important for optimizing intervention strategies.
We examined mediators of behavior change in a tailored-risk communication intervention that increased guideline-based colorectal cancer screening among individuals at increased familial risk.
Participants at increased familial risk for colorectal cancer (N = 481) were randomized to one of two arms: (1) a remote, tailored-risk communication intervention (Tele-Cancer Risk Assessment and Evaluation (TeleCARE)) or (2) a mailed educational brochure intervention.
Structural equation modeling showed that participants in TeleCARE were more likely to get a colonoscopy. The effect was partially mediated through perceived threat (β = 0.12, p < 0.05), efficacy beliefs (β = 0.12, p < 0.05), emotions (β = 0.22, p < 0.001), and behavioral intentions (β = 0.24, p < 0.001). Model fit was very good: comparative fit index = 0.95, root-mean-square error of approximation = 0.05, and standardized root-mean-square residual = 0.08.
Evaluating mediating variables between an intervention (TeleCARE) and a primary outcome (colonoscopy) contributes to our understanding of underlying mechanisms that lead to health behavior change, thus leading to better informed and designed future interventions.
Trial Registration Number
KeywordsColorectal cancer screening Colonoscopy Extended parallel process model Implementation-intention strategies Structural equation modeling
We would like to thank Marc Schwartz, PhD; Antoinette Stroup, PhD; Lisa Pappas, MStat; Rebecca Simmons, PhD, MPH; and Randall Burt, MD for their contributions to the study design and execution. We also thank the interventionists who are genetic counselors in High Risk Clinical Research at Huntsman Cancer Center: Wendy Kohlmann, MS; Amanda Gammon, MS; Kory Jasperson, MS; Anne Naumer, MS; and Lisa Wadge, MS. We thank A.J. Figueredo, PhD, for consulting on the statistical analyses.
Compliance with Ethical Standards
This manuscript included Family Colorectal Cancer Awareness and Risk Education (Family CARE) Project data obtained from the Kinney Research Group and is registered on the ClinicalTrials.gov website (NCT01274143). Family CARE was funded by the National Cancer Institute (1R01CA125194-0305; Kinney, PI) and the Huntsman Cancer Foundation. Family CARE was also supported by the Shared Resources (P30 CA042014) at Huntsman Cancer Institute; the Utah Cancer Registry, which is funded by Contract No. HHSN261201000026C from the National Cancer Institute’s SEER Program with additional support from the Utah State Department of Health and the University of Utah; the California Department of Public Health as part of the statewide cancer reporting program mandated by California Health and Safety Code Section 103885, the National Cancer Institute’s Surveillance, Epidemiology and End Results Program under contract N01PC-2010-00034C awarded to the Northern California Cancer Center, contract N01-PC-35139 awarded to the University of Southern California, and contract N01-PC-54404 awarded to the Public Health Institute, and the Centers for Disease Control and Prevention’s National Program of Cancer Registries, under agreement U58CCU000807-05 awarded to the Public Health Institute; the Colorado Central Cancer Registry program in the Colorado Department of Public Health and Environment funded by the National Program of Cancer Registries of the Centers for Disease control and Prevention; the Cancer Data Registry of Idaho supported in part by the National Program of Cancer Registries of the Centers for Disease Control and prevention; the University of New Mexico Comprehensive Cancer Center Support Grant: Development Funds and the Biostatistics Shared Resource (P30CA118100; C.L.W.); the New Mexico Tumor Registry which is funded by National Cancer Institute Contract No. HHSN261201000033C; the Rocky Mountain Cancer Genetics Network (HHSN261200744000C); the Huntsman Cancer Registry; the University of Utah Department of Orthopaedics and the Center for Outcomes Research and Assessment; and the Intermountain Healthcare Oncology Clinical Program and Intermountain Clinical Genetic Institute. This content is solely the responsibility of the authors and does not necessarily reflect the opinions or views of the funding and supporting agencies.
Authors’ Statement of Conflict of Interest and Adherence to Ethical Standards
Authors Barbara H. Brumbach, Wendy C. Birmingham, Watcharaporn Boonyasiriwat, Scott Walters, and Anita Y. Kinney declare that they have no conflict of interest. All procedures, including the informed consent process, were approved by the Institutional Review Boards of participating institutions and were conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000.
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