Effectiveness and Mechanisms of Multilevel Implementation Strategies to Improve Cancer Prevention Behaviors: A Cluster Randomized Trial

Cancer is a critical national health issue with over 2 million new cancer diagnoses annually within the U.S. and over 600,000 cancer-related deaths. Preventive actions from childhood and adolescence holds great promise in preventing cervical, anal, penile, vaginal, vulvar, and oropharyngeal cancer later in adult life. Yet, little is known about how to leverage this and other facilitators of cancer prevention behaviors in adolescents. Additionally, studies have also revealed multilevel, multifactorial barriers to improving cancer prevention recommendations and critical limitations of health system support. Despite this knowledge, many prior cancer prevention studies in adolescents focus on single-level, single component interventions, leaving many barriers unaddressed. Of studies that are multilevel and/or multi-component, interventions are often pre-selected to address “typical” barriers but are not responsive to unique local barriers and local context. To address this critical gap, we propose a 3-arm cluster randomized controlled trial (RCT) to compare implementation strategies that are multilevel and multicomponent and guided by in-depth understanding of how multilevel factors in the practice settings modify the impact of key facilitators. We will use mixed methods (surveys, interviews, electronic health records) throughout; initially we will evaluate baseline associations between patient-, provider-, and clinic-level factors and variations in cancer prevention behaviors in children and adolescents (Aim 1). In Aim 2, we will compare the effectiveness of: 1) A novel “local-tailored” implementation strategy, co-designed with local care teams to address local barriers and contexts; versus 2) A “prescribed” strategy, typical of most health systems, that involves pre-specified interventions addressing pre-selected cancer prevention barriers; versus 3) Usual care. We will evaluate the effectiveness of these strategies on improving cancer prevention behaviors (primary outcome). Although the need for local tailoring may seem intuitive, it is unknown if local tailoring will yield superior outcomes that could offset the extra investment required, supporting the need for this RCT. We will conduct the study within Kaiser Permanente Southern California, one of the largest community-based care organizations in the U.S. Our study will be guided by the Consolidated Framework for Implementation Research and the Multilevel Factors Across the Cancer Care Continuum framework. Completion of these Aims will generate important insights into the multilevel factors associated with cancer prevention in children and adolescents. This study has high potential to generate critical guidance for diverse health care settings to improve cancer prevention behaviors, ultimately leading to fewer diagnoses of new cancers across the U.S.