Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD

Abstract

Background: Cancer Care Delivery (CCD) research studies often require practice-level interventions that pose challenges in the clinical trial setting. The SWOG Cancer Research Network (SWOG) conducted S1415CD, one of the first pragmatic cluster-randomized CCD trials to be implemented through the National Cancer Institute (NCI) Community Oncology Program (NCORP), to compare outcomes of primary prophylactic colony stimulating factor (PP-CSF) use for an intervention of automated PP-CSF standing orders to usual care. The introduction of new methods for study implementation created challenges and opportunities for learning that can inform the design and approach of future CCD interventions.

Methods: The order entry system intervention was administered at the site level; sites were affiliated NCORP practices that shared the same chemotherapy order system. 32 sites without existing guideline-based PP-CSF standing orders were randomized to the intervention (n = 24) or to usual care (n = 8). Sites assigned to the intervention participated in tailored training, phone calls and onboarding activities administered by research team staff and were provided with additional funding and external IT support to help them make protocol required changes to their order entry systems.

Results: The average length of time for intervention sites to complete reconfiguration of their order sets following randomization was 7.2 months. 14 of 24 of intervention sites met their individual patient recruitment target of 99 patients enrolled per site.

Conclusions: In this paper we share seven recommendations based on lessons learned from implementation of the S1415CD intervention at NCORP community oncology practices representing diverse geographies and patient populations across the U. S. It is our hope these recommendations can be used to guide future implementation of CCD interventions in both research and community settings.

Trial registration: NCT02728596 , registered April 5, 2016.

Keywords: Cancer care delivery; Cluster-randomized; Colony stimulating factor; Computerized clinical decision support system; Intervention.

Conflict of interest statement

SR reports consulting or advisory roles with Bayer Corporation, Bristol-Myers Squibb, AstraZeneca, Merck & Company Inc, Pfizer, Seattle Genetics, Biovica, Genentech (institution); research funding from Bayer Corporation, Bristol-Myers Squibb; and travel accommodations or expenses from Bayer Schering Pharma, Bristol-Myers Squibb, and Bayer. GL reports educational programs or consulting roles with G1 Therapeutics; Partners Healthcare; BeyondSpring; Sandoz; Squibb; Merck; Jazz Pharm; Kallyope; TEVA; Seattle Genetics and Samsung; and research funding from Amgen (Inst). The reported relationships may not relate to the subject matter of this manuscript. All other authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1

Intervention to patient enrollment workflow

Fig. 2

Process to establish a primary prophylactic colony stimulating factor entry protocol