Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions

• Published in: JCO oncology practice Vol. 16; no. 9; p. e859
• Main Authors: Hianik, Rachel S, Campbell, Gavin P, Abernethy, Eli, Lewis, Colleen, Wu, Christina S, Akce, Mehmet, Dixon, Margie D, Shaib, Walid L, Pentz, Rebecca D
• Format: Journal Article
• Language: English
• Published: United States 01.09.2020
• Subjects: Clinical Trials, Phase I as Topic; Communication; Decision Making, Shared; Humans; Medical Oncology; Neoplasms - therapy; Patient Preference
• ISSN: 2688-1535
• DOI: 10.1200/JOP.19.00772

Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient's opinion. We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.