Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Abstract

Background: For many patients with advanced cancer, the decision whether to participate in early phase clinical trials or not is complex. The decision-making process requires an in-depth discussion of patient values. We therefore aimed to synthesize and describe patient values that may affect early phase clinical trial participation. Methods: We conducted a systematic search in seven electronic databases on patient values in relation to patients' decisions to participate in early phase clinical cancer trials. Results: From 3072 retrieved articles, eleven quantitative and five qualitative studies fulfilled our inclusion criteria. We extracted ten patient values that can contribute to patients' decisions. Overall, patients who seek trial participation usually report hope, trust, quantity of life, altruism, perseverance, faith and/or risk tolerance as important values. Quality of life and humanity are main values of patients who refuse trial participation. Autonomy and social adherence can be reported by both trial seekers or refusers, dependent upon how they are manifested in a patient. Conclusions:We identified patient values that frequently play a role in the decision-making process. In the setting of discussing early phase clinical trial participation with patients, healthcare professionals need to be aware of these values. This analysis supports the importance of individual exploration of values. Patients that become aware of their values, e.g. by means of interventions focused on clarifying their values, could feel more empowered to choose. Subsequently, healthcare professionals could improve their support in a patients' decision-making process and reduce the chance of decisional conflict.

“It All Depends”: Patient and Decision Partner Experiences in Cancer Clinical Trial Decision-Making

“…Many participants reported the important role of the physicians. These findings are similar to other studies (Basche et al, 2008; Bell & Balneaves, 2015; Brown et al, 2011; Catt et al, 2011; Galvin et al, 2020; Schapira et al, 2014; Truong et al, 2011; van Lent et al, 2021; Wenzel et al, 2015), where the level of trust patients had in their oncologist’s recommendations regarding whether a clinical trial was an important factor predominantly influenced their decision-making (Brown et al, 2011).…”

Core values of patients with advanced cancer considering participation in an early-phase clinical trial: a qualitative study

“…When patients are able to take a stance of acceptance [ 42 ] toward their situation, the focus can shift to the problems ahead [ 18 ] and the accompanying relevant values. With respect to hope in this article, it seems fair to say that this value combines both hope and perseverance, as mentioned in Van Lent et al [ 36 ]. Whereas perseverance appears in this review as unrealistic or “blind” hope, this study actually showed the flexibility and focus of patients who are willing to explore different paths to achieve their sometimes less realistic goals before downscaling to more realistic goals [ 26 , 29 ].…”

“…In the work of Van Lent et al [ 36 ] and Sulmasy et al [ 32 ], being religiously faithful is presented as a justification for decision-making: God or the gods continue to mean well and will bless those who faithfully chose to participate in early-phase clinical trials. In the current study, however, participants present religious faith more as a comfortable backup for wherever your fate leads you: there is little to no talk about being chosen or becoming the miracle, while there is more talk about faith providing consolation that although your life recently became ill-fated, all will end well for you and your family.…”

“…In a systematic review [ 36 ], we collected all patient values that have been previously reported in the international literature on participation in early-phase clinical trials: hope, trust in the health care system, quality or quantity of life, altruism, social adherence, autonomy, faith, perseverance, risk tolerance, and humanity. However, most previous studies on patients with advanced cancer, such as those by Catt et al [ 4 ] and Walshe et al [ 40 ], refer only to values non-intentionally (i.e., discussing coping mechanisms or reasons for participation), are not always (directly) linked to early-phase clinical trials, and, if so, they are usually focusing on patients after deciding whether or not to participate in such a trial.…”

A Scoping Review of Strategies to Increase Black Enrollment and Retention in Cancer Clinical Trials

“…Patient decisions about enrollment in CCTs also depend on the ability of recruiters to communicate information about the trial or study clearly and effectively, with an understanding of how patients' values may influence their decisions. 24 Morgan et al identified several behaviors among research coordinators, study nurses, and professional recruiters that supported recruitment, such as establishing personal connections, demonstrating respect, expressing empathy, simplifying study information, encouraging questions, equally discussing the risks and benefits of participation, maintaining ongoing contact, and being flexible. 25,26 Eggly et al 27 found that in the setting of a positive patient-provider relationship, there was a significant positive association between oncologists' recommendations and patients' decisions to participate in CCTs.…”