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Updated: May 26, 2025
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Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology
Emily V Dressler1, Stephanie L Pugh2, Heather J Gunn3
1Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC 27157, United States.
Journal of the National Cancer Institute. Monographs
|February 24, 2025
Summary
Cluster randomized controlled trials (cRCTs) in cancer care delivery research face unique challenges. This study shares practical lessons and mitigation strategies for conducting these complex trials within the National Cancer Institute Community Oncology Research Program (NCORP).
Area of Science:
- Oncology
- Clinical Trials
- Health Services Research
Background:
- Cancer care delivery research often uses cluster randomized controlled trials (cRCTs) to evaluate practice or provider-level interventions.
- The National Cancer Institute Community Oncology Research Program (NCORP) network frequently employs cRCTs, requiring cluster-level rather than participant-level randomization.
- Cluster-level randomization impacts sample size calculations and statistical analyses due to intra-cluster correlation.
Purpose of the Study:
- To identify and address practical challenges encountered in conducting cRCTs within the NCORP network.
- To share lessons learned and propose mitigation strategies for common issues in NCORP cRCTs.
- To improve the design and execution of future cancer care delivery research using cRCTs.
Main Methods:
- The study draws on experiences from three specific NCORP cluster randomized controlled trials (cRCTs).
- It examines practical challenges related to trial network infrastructure, participant accrual, and study initiation.
- Considerations for cluster-level stratification, randomization timing, and multilevel eligibility criteria are discussed.
Main Results:
- Unequal participant accrual and staggered study initiation across clusters present significant challenges.
- Unintended cluster-level crossover and the non-accrual of participants in some clusters complicate trial execution.
- Identifying optimal cluster-level stratification and randomization timing requires careful planning.
Conclusions:
- Conducting cRCTs in cancer care delivery research necessitates addressing unique logistical and statistical complexities.
- Proactive strategies are crucial for mitigating challenges related to participant accrual, randomization, and network infrastructure.
- Lessons learned from these NCORP trials can inform the design and implementation of future cancer research networks.
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