Decisional Conflict after Deciding on Potential Participation in Early Phase Clinical Cancer Trials:Dependent on Global Health Status, Satisfaction with Communication, and Timing

SIMPLE SUMMARY: Early phase clinical trials are an essential part of modern drug development and thus the advance of anti-cancer therapies for patients. However, deciding whether to participate in such trials can be complex and patients have reported decisional conflict (i.e., unresolved decisional needs). The aim of our study was to untangle several factors that contribute to decisional conflict in patients with advanced cancer who have recently been asked to decide whether to participate in early phase clinical trials. We found that patients experienced less decisional conflict if they had a better global health status, higher satisfaction, and made their decision sooner. Other factors, such as the decision to (not) participate, did not prove to be the best indicators for decisional conflict. With these insights, we can start to build hypotheses on how to improve the decision-making process for patients with end-stage cancer, which can ultimately improve their quality of life. ABSTRACT: When standard treatment options are not available anymore, patients with advanced cancer may participate in early phase clinical trials. Improving this complex decision-making process may improve their quality of life. Therefore, this prospective multicenter study with questionnaires untangles several contributing factors to decisional conflict (which reflects the quality of decision-making) in patients with advanced cancer who recently decided upon early phase clinical trial participation (phase I or I/II). We hypothesized that health-related quality of life, health literacy, sense of hope, satisfaction with the consultation, timing of the decision, and the decision explain decisional conflict. Mean decisional conflict in 116 patients was 30.0 (SD = 16.9). Multivariate regression analysis showed that less decisional conflict was reported by patients with better global health status (β = −0.185, p = 0.018), higher satisfaction (β = −0.246, p = 0.002), and who made the decision before (β = −0.543, p < 0.001) or within a week after the consultation (β = −0.427, p < 0.001). These variables explained 37% of the variance in decisional conflict. Healthcare professionals should realize that patients with lower global health status and who need more time to decide may require additional support. Although altering such patient intrinsic characteristics is difficult, oncologists can impact the satisfaction with the consultation. Future research should verify whether effective patient-centered communication could prevent decisional conflict

Gender inequality and the double burden of disease in low-income and middle-income countries: an ecological study

Introduction Many low-income and middle-income countries (LMIC) suffer from a double burden of infectious diseases (ID) and non-communicable diseases (NCD). Previous research suggests that a high rate of gender inequality is associated with a higher ID and NCD burden in LMIC, but it is unknown whether gender inequality is also associated with a double burden of disease. In this ecological study, we explored the association between gender inequality and the double burden of disease in LMIC.Methods For 108 LMIC, we retrieved the Gender Inequality Index (GII, scale 0–1) and calculated the double burden of disease, based on disability-adjusted life-years for a selection of relevant ID and NCD, using WHO data. We performed logistic regression analysis to study the association between gender inequality and the double burden of disease for the total population, and stratified for men and women. We adjusted for income, political stability, type of labour, urbanisation, government health expenditure, health infrastructure and unemployment. Additionally, we conducted linear regression models for the ID and NCD separately.Results The GII ranged from 0.13 to 0.83. A total of 37 LMIC had a double burden of disease. Overall, the adjusted OR for double burden of disease was 1.05 per 0.01 increase of GII (95% CI 0.99 to 1.10, p=0.10). For women, there was a borderline significant positive association between gender inequality and double burden of disease (OR 1.05, 95% CI 1.00 to 1.11, p=0.06), while there was no association in men (OR 0.99, 95% CI 0.95 to 1.04, p=0.75).Conclusion We found patterns directing towards a positive association between gender inequality and double burden of disease, overall and in women. This finding suggests the need for more attention for structural factors underlying gender inequality to potentially reduce the double burden of disease

Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention

Abstract Background Patients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making (SDM) models help to understand considerations that influence patients’ decision. Discussion of patient values is essential to SDM, but such communication is often limited in this context and may require new interventions. The OnVaCT intervention, consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists, was previously developed to support SDM. This study aimed to qualitatively explore associations between patient values that are discussed between patients and oncologists during consultations about potential participation in early phase clinical trials before and after implementation of the OnVaCT intervention. Methods This study is part of a prospective multicentre nonrandomized controlled clinical trial and had a between-subjects design: pre-intervention patients received usual care, while post-intervention patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients’ initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached. Results Data saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-intervention and 15 post-intervention). The analysis revealed the values: hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, acceptance of one’s fate, and humanity. Patients in the pre-intervention phase tended to express values briefly and spontaneously. Oncologists acknowledged the importance of patients’ values, but generally only gave ‘contrasting’ examples of why some accept and others refuse to participate in trials. In the post-intervention phase, many oncologists referred to the OnVaCT and/or asked follow-up questions, while patients used longer phrases that combined multiple values, sometimes clearly indicating their weighing. Conclusions While all values were recognized in both study phases, our results have highlighted the different communication patterns around patient values in SDM for potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study therefore provides a first (qualitative) indication that the OnVaCT intervention may support patients and oncologists in discussing their values. Trial registration Netherlands Trial Registry: NL7335, registered on July 17, 2018

Additional file 1 of Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention

Additional file1: Supplementary table 1. Final codebook (i.e. additions and changes to the initial codebook are italicized)