Accentuating patient values in shared decision-making:A mixed methods development of an online value clarification tool and communication training in the context of early phase clinical cancer trials

Objective: In the shared decision-making (SDM) process for potential early phase clinical cancer trial participation, value clarification is highly recommended. However, exploration and discussion of patient values between patients and oncologists remains limited. This study aims to develop an SDM-supportive intervention, consisting of a preparatory online value clarification tool (OnVaCT) and a communication training. Methods: The OnVaCT intervention was developed and pilot-tested by combining theoretical notions on value clarification, with interview studies with patients and oncologists, focus groups with patient representatives and oncologists, and think aloud sessions with patients, following the Medical Research Council (MRC) framework for complex interventions. These human-centered methodologies enabled a user-centered approach at every step of the development process of the intervention. Results: This study shows relevant patient values and oncologists’ perspectives on value exploration and discussion in daily practice. This has been combined with theoretical considerations into the creation of characters based on real-life experiences of patients in the OnVaCT, and how the tool is combined with a communication training for oncologists to improve SDM

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

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

Realizing better doctor-patient dialogue about choices in palliative care and early phase clinical trial participation: towards an online value clarification tool (OnVaCT)

Background: Patients with advanced cancer for whom standard systemic treatment is no longer available may be offered participation in early phase clinical trials. In the decision making process, both medical-technical information and patient values and preferences are important. Since patients report decisional conflict after deciding on participation in these trials, improving the decision making process is essential. We aim to develop and evaluate an Online Value Clarification Tool (OnVaCT) to assist patients in clarifying their values around this end-of-life decision. This improved sharing of values is hypothesized to support medical oncologists in tailoring their information to individual patients’ needs and, consequently, to support patients in taking decisions in line with their values and reduce decisional conflict. Methods: In the first part, patients’ values and preferences and medical oncologists’ views hereupon will be explored in interviews and focus groups to build a first prototype OnVaCT using digital communication (serious gaming). Next, we will test feasibility during think aloud sessions, to deliver a ready-to-implement OnVaCT. In the second part, the OnVaCT, with accompanied training module, will be evaluated in a pre-test (12–18 months before implementation) post-test (12–18 months after implementation) study in three major Dutch cancer centres. We will include 276 patients (> 18 years) with advanced cancer for whom standard systemic therapy is no longer available, and who are referred for participation in early phase clinical trials. The first consultation will be recorded to analyse patient-physician communication regarding the discussion of patients’ values and the decision making process. Three weeks afterwards, decisional conflict will be measured. Discussion: This project aims to support the discussion of patient values when considering participation in early phase clinical trials. By including patients before their first appointment with the medical oncologist and record

Too far to care? The Role of Psychological Proximity in Public Attention and Fear for Ebola

Contains fulltext : 180481.pdf (publisher's version ) (Open Access)10 p

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

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