Разработка Novel Digitals Eliction Measure for Clinical Use у пожилых людей с гематологическими злокачественными свойствами: Ценности-HM.

Introduction

Hematologic malignancies are a group of heterogeneous diseases including leukemia, lymphoma, and multiple myeloma. Roughly 1.3 million people are currently living with blood cancers in the United States, with more than 180,000 new diagnoses made each year. 1 Blood cancers primarily affect older adults, with most patients being diagnosed over the age of 60 y. 2 In the last decade, more than 50 new drug therapies have been approved for blood cancers in the United States, rapidly expanding treatment options and fundamentally changing treatment paradigms. 3 Increasingly, these new drug approvals have enabled oncologists to personalize chemotherapy recommendations to achieve what matters most to individual patients.

Patients with blood cancers differ substantially in what matters most to them. 4 – 8 Some patients prefer to maximize their chances of extended survival time while others prefer to minimize treatment impacts as a means of maintaining their quality of life. This preference heterogeneity leads to differences in ideal treatments. Eliciting patient treatment values is an essential aspect of quality shared decision making and a standard of care. 9 – 11 However, this process is challenging and often poorly executed 12 ; oncologists fail to ask patients about their treatment values in up to 60% of new encounters. 13 Patients frequently report dissatisfaction with communication and report feeling left out and uninformed about treatment options. 14 – 18 Current practice often results in physician perceptions of patient treatment values that are discordant with patient values. 19 – 22 This discordance undermines patient autonomy and results in downstream harm to patients including increased patient distress, lower quality of life, and wasted health care resources. 23 – 26

Values elicitation measures using validated theory-driven methods are increasingly being applied to health care to understand patient values. 27 – 29 Multiple stakeholders have called for the development of validated tools to elicit patient treatment values to improve shared decision making in oncology. 11 , 30 – 33 We developed and refined a values elicitation measure for patients with blood cancers called Values-HM (Values elicitation measure for Hematologic Malignancies) that uses a validated theory-driven preference method called best–worst scaling (BWS). 4 , 34 – 39 BWS is commonly used to assess the priorities of patients and other stakeholders in health and has been used in other clinical settings in oncology. 40 , 41 The development of Values-HM was an iterative process that included data from more than 800 patients, 200 caregivers, and clinical and methodological experts in addition to formal heuristic testing using human-centered design principles. 4 , 34 – 39

This study sought to test the preliminary construct validity of the Values-HM measure and evaluate the initial feasibility, acceptability, and reliability of using the measure with newly diagnosed older adults with blood cancers in a clinical setting. The findings of this study may provide some support for the use of Values-HM in clinical and research settings and provide additional evidence for the development and testing of similar measures for different clinical contexts.

Methods

Study Design

The US Food and Drug Administration (FDA) released a statement on evaluating the quality of patient preference studies to inform clinical care and patient-focused drug development that includes 14 recommended qualities of patient preference studies. 42 This statement is relevant because we developed a patient preference measure to capture patient values. We summarize these 14 qualities and how we applied them to the development of this measure in Table 1 . We followed published guidance on the development and testing of values elicitation measures and published guidance on evaluating the content validity of patient-reported outcome measures to design the study. 29 , 43 , 44 The study was approved by the Institutional Review Board (#21-2282) at the University of North Carolina at Chapel Hill. This trial was registered at www.clinicaltrials.gov as # NCT05061095 . All participants provided written informed consent in compliance with regulatory requirements.

Development of Values-HM

The initial development of the measure has been previously published. 4 , 34 – 36 In sum, we developed the outcomes (objects) of the choice experiment through multistakeholder engagement including clinical experts, patients, and caregivers. 34 Following, we tested a version of the measure in a study with more than 800 patients with acute myeloid leukemia and 200 caregivers. 36 We then tailored the measure for clinical use with older adults with blood cancers by completing a mixed-methods study involving patients, clinicians, and caregivers including qualitative assessments (think-aloud sessions and semi-structured interviews) and questionnaires to iteratively improve the perceived usability and the cognitive workload required to complete the measure. 37 This process led to the refinement of the 7 outcomes included in Values-HM.

Values-HM is a type of BWS measure, an analytically efficient, validated theory-driven preference method that allows for the quantification of the tradeoff importance of objects based on a series of questions (choice tasks). 40 Providing relative importance, or tradeoff preference, is a major strength of BWS compared with Likert scales, in which all outcomes may be rated as equally important. 27 In designing Values-HM, we sought to develop a values elicitation measure that would be valid and reliable to prioritize the values of individual patients in a clinical setting. Values-HM is suitable for analysis on both the cohort and individual level. 37 , 45 The importance scores can be calculated by count analysis, which is simple compared with the regression analysis needed for discrete choice experiments. 46 This analysis results in individual importance scores for each outcome for each individual patient. This output gives clinical teams knowledge as to which outcomes are most important and the relative value that the patient put on each individual outcome compared with other included outcomes.

Participants complete Values-HM choice tasks by selecting 1 outcome that is most important and 1 that is least important. Each choice task contains a subset of 4 of the 7 included outcomes: maintain day-to-day activities, living longer, avoid becoming dependent upon others, avoid short-term side effects, avoid long-term side effects, avoid hospitalizations, and avoid high financial costs. See the example choice task in Figure 1 ; the full measure is included in Appendix Figure 1 . Participants complete a total of 7 choice tasks. A balanced incomplete block design was used to construct the choice sets. 27

Data Collection

Older adults (aged ≥60 y) with newly diagnosed blood cancers were sequentially recruited to participate. Participants were eligible if they were within 28 d of initial diagnosis, had not yet started on initial definitive treatment, and were able to read and communicate in English. We specifically recruited patients with newly diagnosed blood cancers to ensure that the measure was able to capture values in the setting of significant psychological and physical distress, which is common among patients with newly diagnosed blood cancers. 14 , 47 , 48

Participants were recruited remotely and after completing consent were prompted to complete Values-HM, alongside patient-reported outcome measures and study-specific surveys through an online portal to evaluate acceptability. Baseline clinical and demographic information was also captured upon enrollment. After completing their initial consultation with their oncologist, participants were prompted to complete additional surveys and Values-HM. Participants were prompted to complete Values-HM as part of longitudinal assessments initially at a 2-wk interval (up to 5 times) then every 3 mo for up to 2 y.

A subset of participants was asked to complete interviews after the initial treatment decision to evaluate the content validity of the measure. Participants were contacted via phone to schedule a virtual interview at their convenience. Interviews were scheduled within 6 mo of enrollment. Cognitive interviews were conducted in accordance with FDA and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) taskforce guidance on establishing the content validity of patient-reported outcomes measures. 42 – 44 To evaluate participant understanding of outcomes, participants were asked to describe each outcome in their own words. To evaluate the content validity of Values-HM, participants were asked to “think aloud” while completing choice tasks to provide the research team with an understanding of the cognitive process they went through to arrive at answers for each choice task. To assess for missing domains, participants were asked about additional areas that they felt important to include in a values elicitation measure that were not included in Values-HM. A member of our research team with experience in conducting qualitative interviews (C.J.M.) facilitated the interview, while 2 other members took field notes on the interview.

Acceptability, Feasibility, and Validity Assessment

Despite ISPOR recommendations to measure participant acceptability in the development of measures, there are not well-established methods by which to do so. Pilot and developmental studies typically assess acceptability through qualitative interviews. Larger studies have assessed acceptability by asking participants to indicate their level of agreement with several statements including, “I found it easy to understand the questions,”“I found it easy to answer the questions,” and “My answers showed my real preferences.” 28 , 34 , 49 , 50 We followed these studies in assessing participants’ level of agreement with all 3 of these statements after participants completed Values-HM for the first time. We stipulated a threshold of agreement of 70% for acceptability, which is similar to thresholds used in other similar studies. 49 , 51

We assessed the feasibility of clinical implementation (that is, the extent to which Values-HM could be successfully used or carried out within a clinical setting) through the evaluation of rates of consent and completion of the measure. 52 There was no predetermined threshold for feasibility, although we anticipated using rates of completion to inform further work on identifying appropriate implementation strategies for individual contexts.

To begin to explore discriminant validity, the degree to which a measure can distinguish between different constructs, we compared importance weights and confidence intervals among the 7 outcomes. If the measure demonstrated discriminant validity, we would anticipate that the importance weights of each outcome would vary. 53 Conversely, we would expect all importance scores to be clustered around 0 if the measure lacked discriminant validity. Preliminary evidence of convergent validity was explored by comparing each participant’s most important outcome derived from the BWS measure to a ranking exercise. 44 Analysis of variance was used to evaluate differences in variations between within-subject importance scores (within-person variance, test–retest noise or error) and between-subject importance scores (between-subject variance, model variance) to evaluate for test–retest reliability. 54 This approach assumes that differences within persons are error; however, the importance of patient values may change over time due to many clinical and personal factors that are not model error. Thus, this approach is conservative and may overestimate error.

Data Analysis

Data from Values-HM were analyzed using count (frequency) analysis. 46 Descriptive statistics were used to describe the heterogeneity of values based age, sex, and income. Interviews were recorded and coded based on thematic deductive analysis. Cognitive interview question data were used to describe language in the BWS measure for understandability, concept relevance, necessary coverage, and degree of bother. These domains were analyzed qualitatively. 53

Results

Study Participants and Feasibility of Clinical Implementation

Potential participants were identified through a review of the electronic medical record at the University of North Carolina at Chapel Hill (UNC), an academic medical center. UNC serves patients from all counties in North Carolina with a 77% urban and 23% rural population. Most patients (71%) seen at UNC are White. A total of 185 potential participants were identified (see the CONSORT diagram in Figure 2 ). Of those, 164 were approached (88.6%). A total of 51 participants were consented (32% of approached, Appendix Table 1 ). Twenty-nine participants of the 51 consented (56.9%) completed at least 1 survey including Values-HM as part of the baseline surveys ( Table 2 ). The median age was 70 y, with a slight male predominance. Most patients had lymphoma, leukemia, or myelodysplastic syndrome.

Acceptability, Understandability, and Relevance

Twenty-six participants (89.7%) completed at least 1 survey to evaluate acceptability, understandability, and relevance. Eighty-five percent (22/26) of participants agreed or strongly agreed that the measure was understandable. Seventy-three percent (19/26) of participants agreed or strongly agreed that the measure showed their real preferences, 54% (14/26) felt the measure was easy to answer, and 88% (23/26) of participants felt the measure was relevant. Nineteen of the 26 participants (73%) completed additional study-associated surveys after making a treatment decision. Of these, 68% (13/19) agreed or strongly agreed that the measure was acceptable to clarify their preferences.

Convergent and Discriminant Validity

The measure demonstrated convergent validity with a simple ranking exercise of the outcomes: of the 26 participants who fully completed baseline ranking and the BWS measure, 77% (20) had convergence of the top priority on Values-HM with 1 of their top 3 ranked outcomes including 14 of 20 (70%), of which the top outcome was the same in both the ranking exercise and the BWS measure. In 72% (21) of participants, no conflicts were found comparing their BWS least important to the top 3 ranking. Of the participants who had conflicts, 2 had complete mismatches in which their BWS least important outcome was the outcome they chose in the ranking exercise as most important. The Values-HM measure resulted in disparate importance scores and confidence intervals for individual outcomes suggesting discriminant validity (see the “Most and Least Important Treatment Values” section below).

Test–Retest Reliability

Eighteen participants completed Values-HM more than once as part of repeated assessments. Of patients who completed Values-HM more than once, the median number was 8. The median time from the first completion to the second completion was less than 30 d. These data were used to compare differences in variations between within-subject importance scores (error) and between-subject importance scores (model) to evaluate for test–retest reliability. Differences were statistically significant for the following outcomes: avoid becoming dependent on others (mean square for model [MS_m] 3.60, mean square for error [MS_e] 1.41, P = 0.002), avoid high financial costs (MS_m 3.90, MS_e 1.17, P < 0.001), avoid long-term side effects (MS_m 4.35, MS_e 0.80, P < 0.001), and avoid hospitalizations (MS_m 4.89, MS_e 0.64, P < 0.001) ( Appendix Table 2 ). Differences approached statistical significance for the other outcomes: avoid short-term side effects (MS_m 1.93, MS_e 1.21, P = 0.08, living longer (MS_m 2.56, MS_e 1.56, P = 0.06), and maintain day-to-day activities (MS_m 1.52, MS_e 1.13, P = 0.18). There was the most variability in the population (MS_m) for avoid hospitalizations, avoid long-term side effects, and avoid high financial costs. Maintain day-to-day activities and avoid short-term side effects had the lowest population variability. These data suggest that, in general, there was more variation in the population (model) than within participants (assumed error), which suggests reliability of the measure for capturing repeated measurements over time.

Content Validity

Ten participants completed cognitive interviews to assess several aspects of content validity of the included outcomes in Values-HM. Data saturation was reached at 10 interviews. Results are summarized in Table 3 . All participants were able to accurately describe the instructions of Values-HM. All participants were able to correctly define each included outcome. All patients understood the choice task, although some found completing the choice task challenging due to difficulty choosing between or among multiple important factors. Patients frequently cited individual experiences that led them to choose specific outcomes in some choice tasks. Suggested improvements included addressing pain levels, enhancing communication with providers, and incorporating aspects of psychological support and individual circumstances into the tool. All patients reported it was beneficial. No patients reported missing domains of outcomes.

Most and Least Important Treatment Values

The most and least important treatment values for the entire cohort at baseline are shown in Figure 3a . Maintaining day-to-day activities was the most important outcome for the cohort (mean importance score [mean best-minus-worst scores, max 4, min −4] 1.48, 95% confidence interval [CI] 0.70, 2.27), followed by living longer (0.97, 95% CI 0.00, 1.93), avoiding becoming dependent on others (0.55, 95% CI −0.21, 1.32), avoiding hospitalizations (0.38, 95% CI −0.24, 1.00), avoiding long-term side effects (−0.21, 95% CI −0.86, 0.45). Avoiding short-term side effects (−1.59, 95% CI −2.17, −1.00) and avoiding high financial costs were the least important (−1.59, 95% CI −2.35, −0.83).

The individual-level analysis of the most and least important values at baseline is shown in Figure 3b . Results from best–minus worst scoring were the same (“tied”) for 4 patients for their most important value and 8 patients for their least important value. The most important values (including ties) for individual patients were living longer ( n = 10, 34% of patients) and maintaining day-to-day activities ( n = 10, 34%). The least important values were avoiding high financial costs ( n = 13, 45%) and avoiding short term side effects ( n = 8, 28%). While 10 patients (34%) chose living longer as most important, 5 patients (17%) chose it as least important. Only 1 patient chose maintaining day-to-day activities as least important. One patient chose avoiding high financial costs as most important, while no patients chose avoiding short-term side effects as most important.

We assessed the heterogeneity of values based on age, sex, and income, although the statistical analysis was limited by the relatively small sample size. For patients aged >70 y, 7 of 17 (41%) chose maintain day-to-day activities as most important, while 4 of 12 (33%) patients aged <70 y chose it as most important. Similarly, for patients aged >70 y, 7 of 17 (41%) chose living longer as most important, whereas 4 of 12 (33%) of patients aged <70 y chose it as most important. Sex did not appear to be associated with differences in values. For those making $75,000 or more, most chose avoid high financial costs as least important (10/13, 77%) while only 2 of 12 (16%) patients making less than $75,000 chose it as least important.

Discussion

A critical first step toward the routine integration of patient values into clinical care is the development of validated clinical measures. Values-HM is a theory-driven values elicitation measure developed for clinical use for patients with blood cancers using best practices for measure development. We followed guidance from the FDA ( Table 1 ) and ISPOR in developing Values-HM and reporting results. This study builds on several prior studies involving patients, caregivers, and clinicians. 35 – 38 , 48 Data from quantitative surveys and cognitive interviews in this study expand on previous work demonstrating that most older adults with blood cancers found the measure relevant to them, acceptable to clarify their preferences, and understandable. Cognitive interviews with participants demonstrated that participants actively engaged in the process of completing each choice task using reflective and analytical approaches to weigh each of the outcomes and arrive at their response, demonstrating high engagement with the measure in the process of values clarification. The measure demonstrated some level of discriminant validity and convergent validity with other value elicitation methods. The measure also showed evidence of reliability in repeated measurement over time. Together, these data provide preliminary evidence that Values-HM may be valid for clinical use.

We designed Values-HM to be clinically actionable. 37 – 39 , 55 Therefore, in this study we sought to produce initial evidence of validity and reliability in a clinical setting with individual patients. Values-HM provides individual importance scores for 7 outcomes that are most important to older adults with cancer. Prior studies suggest that these importance scores may support clinical teams to align care to what matters most to each patient. 38 Values-HM is not a decision aid to determine therapy but rather a decision support tool intended to foster engagement between patients and clinicians (who are disease experts) to integrate patient values into many different treatment paradigms. We designed Values-HM to be treatment and disease agnostic so that it could be widely used across different disease and treatment decisions even as disease paradigms change over time or as new therapies are developed. This provides clinicians and researchers flexibility in using Values-HM depending on the context. Values-HM could be collected prior to a patient visit, for example, through a patient portal or in the waiting room, to support shared decision making or longitudinally to inform ongoing care.

Because Values-HM is built on discrete choice methodology, it functions as both a values elicitation and values clarification tool. When patients complete Values-HM, it is necessary for them to “tradeoff” what matters most to them among 7 important outcomes. This is not an easy task (as noted by nearly half of respondents) because it requires prioritizing between living longer and maintaining aspects of quality of life such as day-to-day activities or independence and carefully weighing the tradeoffs between quantity and quality of life. In the end, most treatment decision making for older adults is similar to this process—deciding a direction among many options with competing risks and benefits. This similarity makes us believe that Values-HM could be helpful in preparing patients to make a treatment decision among options with competing risks and benefits.

We foresee that Values-HM may be most useful for patients with newly diagnosed or newly relapsed disease as treatment decisions in these contexts are naturally contingent on patient values. We developed Values-HM with patients with newly diagnosed blood cancers because this specific treatment context is often the most challenging for patients. Patients experience high levels of distress, uncertainty, and fear and find making initial treatment decisions troubling. 14 , 48 As such, the use of the measure with patients with newly diagnosed disease is most appropriate, although it seems reasonable that the measure may be helpful in similar treatment decision scenarios such as relapse. While Values-HM was specifically designed for patients with blood cancers, further studies may demonstrate that it is useful beyond this population as well.

We believe that using Values-HM together with validated frailty measures—especially validated geriatric assessments—is the best way to properly inform treatment decisions. Assessing patient values and preferences alongside validated geriatric assessments is optimal to improve outcomes. 56 – 58 This is because understanding patient values together with functional/frailty data is essential for clinicians to adequately understand and discuss the individualized risk–benefit tradeoffs facing each older adult with cancer. 9 , 57 – 59 Using this measure alongside the Practical Geriatric Assessment would be an efficient way to capture values and other critical domains. 58 In this study, we did not provide the results of Values-HM to patients; however, in our subsequent work, we discovered that real-time feedback was valued by patients to inform shared decision making. 38 , 39 , 55 Therefore, we now routinely provide individual results from Values-HM to all patients in real time.

This study adds to prior work demonstrating that many older adults with cancer prioritize aspects of quality of life over survival. 4 , 60 , 61 Many therapeutic clinical trials, which are essential to test novel treatments, are not designed with quality of life as the primary endpoint but rather overall survival. This may result in discordance between patient values and trial endpoints. Using values elicitation measures such as Values-HM as part of screening for clinical trials may help identify patients whose values are aligned with clinical trial endpoints or to prompt a discussion of alternative treatments that are more appropriate. Recruiting more “value-aligned” patients may result in higher recruitment, more engaged participation, and a reduction in dropout. Given that recruitment of older adults to treatment trials has historically been poor, 62 this would be a substantial improvement.

This work provides a proof of principle for those who desire to develop tools to capture patient preferences or values in real time to inform clinical care. However, more scientific advances are necessary to see routine values assessment be integrated into the care of all older adults. A critical next step is to begin to identify implementation strategies. We envision Values-HM being collected alongside other electronic patient-reported outcomes (ePROs) via a patient portal or in person via a tablet with results provided to clinicians prior to treatment decisions. Many cancer centers are investing in platforms to collect ePROs given the proven benefits to their routine collection during cancer treatment. 63 , 64 These efforts likely will identify several appropriate strategies for the implementation of values elicitation measures. 65 , 66 Despite the similarity between ePROs and values elicitation measures, unique questions about the implementation of values elicitation measures remain, including: What is the best values elicitation method for each context? How do we apply patient values to different clinical contexts? How frequently should values be elicited? Can we use screening measures to reduce survey burden? In addition, other studies are necessary to evaluate the effect of using values elicitation measures on treatment decision making and other downstream outcomes. We are currently testing the effect on shared decision making of Values-HM and a similar measure we designed in randomized clinical trials for older adults with blood cancers ( NCT06296368 , NCT06697600 ). 67 These studies will help demonstrate how these measures affect the quality of decision making, patient distress, and health care utilization. The use of other shared decision-making tools have shown downstream benefits with varying degrees in different settings. 25

Limitations

There is a lack of clear guidance for the development of values elicitation measures that are to be used in a clinical setting. Therefore, our methods in combining advising bodies’ recommendations are subject to error. There are no benchmarks to determine validity and reliability for values elicitation measures. This makes the interpretation of our data particularly challenging.

Based on findings from similar studies, we anticipated that it may be challenging to recruit older participants with newly diagnosed blood cancers within the necessary recruitment window between diagnosis and treatment. 2 Unfortunately, the recruitment rate and the completion rate of Values-HM in this study were still both lower than anticipated, prompting us to complete a post hoc analysis of barriers to completion. In this analysis, we found that patients found the online consent process inefficient and frequently did not return to complete subsequent measures due to the cumbersome electronic delivery platform of Values-HM. 55 We now have employed several implementation science strategies to reduce patient burden in consent and completing Values-HM, which we have employed as part of the ongoing randomized controlled trial. 55 With these changes, completion rates of the measure on that trial are greater than 80%. This improvement in completion rates demonstrates that the low completion rates in the current study were due to identified barriers, not inherent to Values-HM as a measure. While this demonstrates that it is feasible to use Values-HM in clinical care, it also highlights the importance of identifying local resources to support older adults in the completion of measures during this vulnerable time.

White participants were overrepresented in this study compared with our clinical population. Four Black participants and 1 Asian participant consented to the study, which together represented 9.7% of the total population consented. Unfortunately, of these 5 patients, only 1 patient completed Values-HM. This substantially limited the racial diversity of the sample completing Values-HM and reduces our confidence in the generalizability of our findings. Although there was adequate representation of patients from minority backgrounds in the developmental studies of Values-HM, 4 , 34 – 36 further work evaluating the feasibility, acceptability, and validity of using Values-HM in these populations would be valuable. We are assessing data regarding the engagement of minority populations in the follow-up RCT ( NCT06296368 ).

Conclusion

Validated measures to assess the values of patients with blood cancers are needed to better align treatment decisions to what matters most to patients. Values-HM is a values elicitation measure developed specifically to support clinical decision making for older adults with blood cancers. In this initial validation study involving mostly older White patients, the measure was acceptable to patients and appeared valid and reliable to capture patient values to inform treatment decision making. Further work is needed to develop optimal implementation strategies for values elicitation measures such as Values-HM and to optimize the use patient preference data in different populations to improve clinical care.

Supplemental Material

sj-docx-1-mpp-10.1177_23814683261440935 – Supplemental material for Developing a Novel Values Elicitation Measure for Clinical Use in Older Adults with Hematologic Malignancies: Values-HM

Supplemental material, sj-docx-1-mpp-10.1177_23814683261440935 for Developing a Novel Values Elicitation Measure for Clinical Use in Older Adults with Hematologic Malignancies: Values-HM by Daniel R. Richardson, Allison M. Deal, Carl J. Mhina, Matthew Washko, Amy C. Cole, Norah L. Crossnohere, Kah Poh Loh, Ethan Basch, Stephanie B. Wheeler, William A. Wood, John F. P. Bridges, Thomas W. LeBlanc and Antonia V. Bennett in MDM Policy & Practice

sj-pdf-2-mpp-10.1177_23814683261440935 – Supplemental material for Developing a Novel Values Elicitation Measure for Clinical Use in Older Adults with Hematologic Malignancies: Values-HM

Supplemental material, sj-pdf-2-mpp-10.1177_23814683261440935 for Developing a Novel Values Elicitation Measure for Clinical Use in Older Adults with Hematologic Malignancies: Values-HM by Daniel R. Richardson, Allison M. Deal, Carl J. Mhina, Matthew Washko, Amy C. Cole, Norah L. Crossnohere, Kah Poh Loh, Ethan Basch, Stephanie B. Wheeler, William A. Wood, John F. P. Bridges, Thomas W. LeBlanc and Antonia V. Bennett in MDM Policy & Practice

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article. NLC reports consulting or advisory roles at Boehringer Ingelheim and travel, accommodations, and expenses from Bausch and Lomb. EB reports consulting or advisory roles at AstraZeneca, N-Power Medicine, Navigating Cancer, Resilience Care, Savor Health LLC, Thyme Care, and Verily and other relationships with the American Society of Clinical Oncology, Centers for Medicare and Medicaid Services, National Cancer Institute, and the Patient-Centered Outcomes Research Institute (PCORI). SBW has received research funding from AstraZeneca and Pfizer and travel, accommodations, and expenses from Pfizer. WAW reports stock and other ownership interests in Koneska Health; consulting or advisory roles at ASH Research Collaborative, Koneska Health, and Teledoc Health; research funding from Pfizer, Genetech. JFPB reports consulting or advisory roles at Boehringer Ingelheim; and travel, accommodations, and expenses from Boehringer Ingelheim. TL reports stock and other ownership interests at Dosentrx and Thyme Care; honoraria from Genentech and Lilly; consulting or advisory roles at Abbvie/Genentech, Agios/Servier, Apellis Pharmaceuticals, Astellas Pharma, Bristol-Myers Squibb/Celgene, Gilead Sciences, GlaxoSmithKline, Menarini Group, Novartis, and Pfizer; Speakers’ Bureau at Abbvie, Bristol-Myers Squibb/Celgene, GlaxoSmithKline, Incyte, Menarini, Rigel, and SERVIER; research funding from Abbvie, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Jazz Pharmaceuticals, Novartis; royalties from UpToDate Inc.; travel, accommodations, and expenses from Abbvie/Genentech, Astellas Pharma, Bristol-Myers Squibb/Celgene, Incyte, Menarini, Rigel, and SERVIER. All other authors have no conflicts to disclose. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Palliative Care Research Cooperative group (to DRR) and the Carolina Medical Student Research Program (to MFW). Financial support for this study was provided in part by a grant from the Palliative Care Research Cooperative Group through a larger grant from the National Institute of Nursing Research. The funding agreement ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report.

Author Contributions: DRR, NLC, WAW, JFPB, TWL, and AVB, designed the research; DRR, CJM, MW, and ACC performed the research; DRR, CJM, MFW, and ACC collected the data; DRR, AMD, CJM, MFW, ACC, NLC, KPL, EB, SBW, WAW, JFPB, and AVB analyzed and interpreted the data; DRR, AMD, CJM, and MFW performed the statistical analysis; and DRR, AMD, NLC, JFPB, TWL, and AVB wrote or edited the manuscript.

Ethical Considerations: The study was approved by the Institutional Review Board (#21-2282) at The University of North Carolina at Chapel Hill. This trial was registered at www.clinicaltrials.gov as # NCT05061095 .

Consent to Participate: All participants provided written informed consent in compliance with regulatory requirements.

Consent for Publication: Not applicable.

ORCID iDs: Daniel R. Richardson https://orcid.org/0000-0001-9310-5773

Amy C. Cole https://orcid.org/0000-0001-9478-6005

Norah L. Crossnohere https://orcid.org/0000-0002-2811-1330

Ethan Basch https://orcid.org/0000-0003-3813-9318

Data-Sharing Statement: Data can be requested via e-mail to the corresponding author.

Clinical Trial Data Sharing: De-identified participant data will be transferred to the Palliative Care Research Cooperative Group (PCRC) repository for dissemination once published.

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