An Online Decision Aid for Patients With Metastatic Melanoma­Results of the Randomized Controlled Trial "PEF-Immun".

BACKGROUND: Treatment decisions in metastatic melanoma (MM) depend on patient preferences and require the patients' involvement in the decision-making process. Patients often feel overwhelmed by the complexity of treatment options with their individual advantages and disadvantages. We developed an online patient decision aid (PtDA) to facilitate shared decision making (SDM). METHODS: We conducted a two-center, two-armed, prospective, open randomized controlled trial with MM patients who were facing a decision about first-line treatment. They were randomly allotted (1:1) to the use or non-use of the PtDA before discussing the choice of treatment with a physician (intervention group [IG] and control group [CG], respectively). The primary endpoint of the study was patient knowledge about first-line treatment options (multiple-choice test, 10 items, range 0-40 points). The secondary endpoints were the degree of SDM (ratings of audio recordings of the patient-physician discussions by third-party observers) and satisfaction with the decision that was taken on later follow-up. RESULTS: 120 of the 128 randomized patients completed the baseline questionnaire and were included in the analysis (59% male, median age 66 years). The primary endpoint, i.e., the mean difference in knowledge after discussion with a physician, was significantly higher in the intervention group (mean difference -3.22, 95% CI [-6.32;-0.12], p = 0.042). No difference was found in either of the secondary endpoints (SDM and satisfaction with the decision). The patients in the intervention group rated the PtDA as very useful. CONCLUSION: PtDA improved MM patients' knowledge about their options for treatment. Both patients who used it and patients who did not were highly satisfied with their treatment decisions. Additional physician training seems necessary to promote SDM.

Preferred and perceived participation roles of oncological patients in medical decision-making: Results of a survey among users of the German Cancer Information Service.

BACKGROUND: Cancer patients are facing a variety of treatment and other disease-related decisions. This study aims to provide insights into preferred and perceived participation roles in decision-making among patients with diverse tumors using the German Cancer Information Service (CIS). METHODS: Patients' decision-making preferences and experiences were assessed as a part of a cross-sectional survey among CIS users. An adapted version of the Control Preferences Scale (CPS) was used to assess preferred and perceived participation roles in eight different areas of medical decision-making (e.g., choice of medication, termination of treatment). Logistic regression analyses were applied to explore preference matching and to analyze associations between participation roles and sociodemographic variables. Moreover, we examined preferences and perceptions of participation roles across different decision situations. RESULTS: In the final sample (N = 1566, 64.9% female, mean age = 61.6), almost half of the patients (47.1%) preferred to take a collaborative role in decisions on treatment methods, whereas 36.3% preferred an active role and 15.9% a passive role. Collaborative role preferences frequently (40.7%) coincided with experiencing a passive role and predicted a reduced chance of a match between preferences and experiences (OR = 0.57, p = .001). A higher level of education was associated with a lower chance of preferring and perceiving a passive role (OR = 0.85, p < .01). Compared with men, women had increased odds of preferring (OR = 1.45, p < .05) and of actually taking (OR = 2.04, p < .001) a passive role in medical encounters. Preferred participation roles regarding treatment methods were highly correlated with preferences in all other decision areas (r > .50, p < .001) except decisions about family involvement. CONCLUSIONS: The study reveals well-known deficits in the fulfilment of patients' collaborative role preferences across different areas of medical decision-making in a sample of CIS users characterized by high information-seeking behavior. Participation roles were not only influenced by the patients' level of education but also by their gender. The gender effect may be more pronounced than previous studies suggest. These effects should be considered in the development of interventions to promote shared decision-making. Additionally, study results indicate that preferences for participation in decisions about treatment methods, as assessed by the CPS, can be generalized to other areas of medical decision-making.

Associations between burnout symptoms and social behaviour: exploring the role of acute stress and vagal function.

BACKGROUND: The study aimed to investigate the link between burnout symptoms and prosocial behaviour, as well as the role of acute stress and vagally-mediated heart rate variability (vmHRV) on this association. METHODS: Seventy men were randomly assigned to either the stress or the control condition of the Trier Social Stress Test for Groups (TSST-G). Prosocial behaviour was assessed via a social decision-making paradigm during the respective TSST-G condition. RESULTS: Correlation analyses revealed negative correlations between prosocial behaviour and burnout symptoms. Acute stress was also associated with reduced prosocial behaviour, whereas no interaction effects with burnout symptoms could be revealed. Exploratory analyses showed that vmHRV was negatively correlated with burnout symptoms during the social decision-making paradigm but did not mediate the link between burnout and prosocial behaviour. CONCLUSION: In conclusion, we report first experimental evidence that burnout symptoms are negatively associated with prosocial behaviour. Further studies are needed to explore the causal relations.

Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial.

BACKGROUND: Patients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients' knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction. METHODS: In total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient's knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2. DISCUSSION: This trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma. TRIAL REGISTRATION: ClinicalTrials.gov NCT04240717 . Registered on 27 January 2020.