@article{63bbf1d9ea5e40f681a2057c503d81e5,
title = "Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)",
abstract = "Introduction: Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning. Methods: We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients. Results: Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient. Conclusion: We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.",
keywords = "Cluster-randomized design, healthcare delivery research, prostate cancer, shared decision-making",
author = "Pacyna, {Joel E.} and Dueck, {Amylou C.} and Chang, {George J.} and Selina Chow and Paskett, {Electra D.} and Simon Kim and Tilburt, {Jon C.}",
note = "Funding Information: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Dr E.D.P. is the MPI on a grant to her institution from Merck Foundation and another from Pfizer. Dr E.D.P. also receives grant funding to her institution from the Breast Cancer Research Foundation. None of Dr E.D.P.{\textquoteright}s disclosures is related to this work. There are no other disclosures to report. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Research reported in this publication was supported by a grant from the National Institute on Minority Health and Health Disparities (R01MD008934) and the National Cancer Institute of the National Institutes of Health under the Award Number UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant), UG1CA232760, UG1CA233329, and UG1CA233331 ( https://acknowledgments.alliancefound.org ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Publisher Copyright: {\textcopyright} The Author(s) 2023.",
year = "2023",
doi = "10.1177/17407745231167123",
language = "English (US)",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
}