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

Abstract

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials

“…In other words, the study results indicated that the recruited patients with lung and liver cancer understood the trial, although SDM was not directly explained or observable. Unlike previous researchers who focused on the relationship between SDM and the treatment consent process in clinical trials, 20 we did not compare 2 situations where a healthcare provider should recommend a trial to the patient regardless the SDM process. The study did not indicate the SDM process' objective aspect, whereas we assessed patient-reported SDM.…”

“…Shared decision-making (SDM), which involves collaboration between patients and their physicians to make treatment decisions that improve patient compliance, has been recommended in medical settings for decades. 18 , 19 However, previous studies 4 , 20 , 21 have mainly focused on the relationship between SDM and the treatment consent process in the clinical, non–informed consent SDM in the clinical trials context. One recommendation is to apply SDM in oncology settings, including explicit discussions of standard-of-care options or clinical trials for patients.…”

“…One recommendation is to apply SDM in oncology settings, including explicit discussions of standard-of-care options or clinical trials for patients. 20 The researchers analyzed all providers’ conversations with explicit patient recommendations for the Phase I trial. They found that most conversations followed the structure of the SDM process.…”

Motivations and experiences of patients with advanced cancer participating in Phase 1 clinical trials: A qualitative study

“…2,4,7,9–13 However, many are motivated by unrealistic hope regarding trial outcomes, fuelled by misconceptions about trial aims and outcomes. 7,8,14,15 Even where there is adequate information provided and a realistic understanding of prognosis, patients may still hold on to apparently incongruous hopes for extraordinary outcomes. 12,16–18…”

“…2,4,7,[9][10][11][12][13] However, many are motivated by unrealistic hope regarding trial outcomes, fuelled by misconceptions about trial aims and outcomes. 7,8,14,15 Even where there is adequate information provided and a realistic understanding of prognosis, patients may still hold on to apparently incongruous hopes for extraordinary outcomes. 12,[16][17][18] Exploration of patient's values and goals while navigating the decision-making process of whether or not to participate in a Phase 1 clinical trial may be supported by healthcare professionals in palliative care.…”