Contemplating participation in early phase clinical cancer trials:Integrating patient values in communication and decision-making through an online value clarifi cation tool intervention

In this PhD thesis, Liza van Lent describes the development and evaluation of an Online Value Clarification Tool (OnVaCT) intervention. The intervention aimed to support patients with incurable cancer and oncologists in the shared decision-making process for potential participation in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Improving patients' decision-making process is beneficial for their quality of life. Particularly for patients with an incurable disease, such as those with advanced cancer, a well-balanced decision-making process can help them to spend the limited time towards the end of their lives in line with their personal values and beliefs. Consequently, integrating patient values in communication and shared decision-making is important.Based on systematic literature review and interviews with patients, several relevant patient values were identified in the context of contemplating potential participation in an early phase clinical trial. These values, inspired by patients’ and oncologists’ personal experiences, were integrated into the OnVaCT with communication training. This OnVaCT intervention did not make the external circumstances of the decision less uncertain or complicated for patients: both before and after implementation of the intervention, patients experienced ‘decisional conflict’ (i.e. unresolved decisional needs, such as feelings of insecurity). However, the intervention has considerably improved the shared decision-making process in clinical practice. Specifically, oncologists involved patients more in all steps of shared decision-making, including the discussion of patient values and goals of care. This PhD thesis has thereby contributed to a better conversation and better shared-decision making process in which patient values are central.<br/

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.</p

Grief after Pandemic Loss:Factors Affecting Grief Experiences (the CO-LIVE Study) (#236876363)

It has been suggested that grief after losing a significant other person during the COVID-19 pandemic is more severe than before the pandemic. However, little is known about the factors associated with COVID-19-related grief. This study aims to examine whether grief among relatives of people who died during the first COVID-19 wave was associated with factors such as (in)sufficient opportunity to be with the dying person, relatives’ appreciation of how the person died, and “unfinished business” between the bereaved and the deceased. The study involved 200 Dutch relatives who had lost a person during the pandemic. Grief was measured with the Hogan Despair subscale. Data were analyzed using correlations and multivariable regression analysis. Our findings revealed that two-thirds of bereaved relatives reported that they had not had sufficient opportunity to be with the dying person in the final days. However, this experience was not significantly correlated with despair. A negative appreciation of the dying process and remaining unfulfilled wishes as part of “unfinished business” between the dying person and their relative were associated with higher levels of despair, particularly among partners. It is crucial to ensure that relatives can experience good end-of-life care for their dying loved one and be enabled to resolve family issues, to mitigate the impact of the pandemic.</p

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

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.</p

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

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.</p

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

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

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

Contemplating participation in early phase clinical cancer trials:Integrating patient values in communication and decision-making through an online value clarifi cation tool intervention

In this PhD thesis, Liza van Lent describes the development and evaluation of an Online Value Clarification Tool (OnVaCT) intervention. The intervention aimed to support patients with incurable cancer and oncologists in the shared decision-making process for potential participation in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Improving patients' decision-making process is beneficial for their quality of life. Particularly for patients with an incurable disease, such as those with advanced cancer, a well-balanced decision-making process can help them to spend the limited time towards the end of their lives in line with their personal values and beliefs. Consequently, integrating patient values in communication and shared decision-making is important.Based on systematic literature review and interviews with patients, several relevant patient values were identified in the context of contemplating potential participation in an early phase clinical trial. These values, inspired by patients’ and oncologists’ personal experiences, were integrated into the OnVaCT with communication training. This OnVaCT intervention did not make the external circumstances of the decision less uncertain or complicated for patients: both before and after implementation of the intervention, patients experienced ‘decisional conflict’ (i.e. unresolved decisional needs, such as feelings of insecurity). However, the intervention has considerably improved the shared decision-making process in clinical practice. Specifically, oncologists involved patients more in all steps of shared decision-making, including the discussion of patient values and goals of care. This PhD thesis has thereby contributed to a better conversation and better shared-decision making process in which patient values are central.<br/