Key result
This study protocol describes a quasi-randomized controlled trial to evaluate the eCROPS-CA cancer prevention package among 4,320 high-risk farmers in rural China, with no results yet available.
Why the study?
Does the eCROPS-CA intervention package reduce the incidence of leading cancers in high-risk rural farmers?
RCT (n=4,320)
Open-label
Cluster randomized
Yes
Does the eCROPS-CA intervention package reduce the incidence of leading cancers in high-risk rural farmers?
This study protocol outlines a quasi-RCT to evaluate a comprehensive, village doctor-led cancer prevention package (eCROPS-CA) in rural China.
Protocol alone yields no efficacy data; leaves open whether eCROPS-CA reduces cancer incidence among high-risk rural farmers.
BACKGROUND: Effective prevention against cancers depends heavily on sustained individual efforts practicing protective behaviors and avoiding risk factors in a complex sociocultural context, which requires continuous and personalized supports. Contemporary prevention relies primarily on strategies targeting general population with limited attention being paid to individualized approaches. This study tests a novel package called, in acronym of core intervention components, eCROPS-CA that leverages protective behaviors against over 80% leading cancers among high risk individuals via continuous and tailored counseling by village doctors. METHODS/DESIGN: The study utilizes a quesi-RCT design involving 4320 high risk individuals selected, via rapid and detailed risk assessments, from about 72,000 farmers aged 35+ in 36 administrative villages randomized into equal intervention and delayed intervention arms. The intervention arm receives baseline and semiannual follow up evaluations plus eCROPS-CA for 5 years; while the control arm, only the baseline and follow-up evaluations for the first 5 years and eCROPS-CA starting from the 6(th) year if the intervention is proved effective. eCROPS-CA comprises electronic supports and supervision (e), counseling cancer prevention (C), recipe for objective behaviors (R), operational toolkit (O), performance-based incentives (P), and screening and assessment (S). Evaluation measures include: incidence and stage of the leading cancers, cancer-related knowledge, attitudes and practices; easy biophysical indicators (e.g., body mass index, blood pressure); intervention compliance, acceptance of the package. DISCUSSION: The prevention package incorporates key success factors in a synergetic way toward cost-effectiveness and long-term sustainability. It targets a set rather than any single cancer; choses village doctors as key solution to the widespread lack of professional manpower in implementing personalized and thus relatively sophisticated prevention; adopts real-time monitoring in reaching continuous improvement; utilizes smart web aids to enable prioritizing complex determinants of objective behaviors, linking counseling sessions happened at different time points and hence delivering highly coordinated prevention; uses 2-stage risk assessment models in identifying high risk individuals so as to focus on the most needed; applies standardized operation procedures in simplifying and smoothing behavior intervention yet ensuring delivery of essential steps and key elements. TRIALS REGISTRY: ISRCTN33269053.
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Chai et al. (2015) conducted an RCT in Cancer prevention (n=4,320). eCROPS-CA vs. Delayed intervention was evaluated on Incidence and stage of the leading cancers. This study protocol describes a quasi-randomized controlled trial to evaluate the eCROPS-CA cancer prevention package among 4,320 high-risk farmers in rural China, with no results yet available.
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