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End-of-life characteristics associated with short hospice length of stay for patients with solid tumors enrolled in phase I clinical trials
Article
Background: The ethical and clinical issues regarding phase I cancer trials have been debated for decades, with concerns of therapeutic misconception and misestimation of individual benefit by participants. Although investigators may note clinical responses, especially in an era of more rational drug design and targeted therapy, the typical aims of a phase I trial are dose-finding and a preliminary assessment of the safety and tolerability of a new agent or drug combination. Patients enrolled in phase I trials typically have symptoms at baseline, which worsen as a result of disease progression, treatment, or both. Patients who are eligible for phase I trials are a highly motivated group who functionally have a better performance status than other patients with advanced cancer. Previous research has suggested that they may differ from similar individuals with advanced cancer in their preference to pursue additional treatment, even when treatments have a low chance of success. This combination of toxic drugs, terminal patients, and the low likelihood of direct benefit may expose patients to a risk of adverse effects beyond drug-related toxicity, including limited advance care planning (ACP) and suboptimal end-of-life (EOL) care.
The 2015 consensus report Dying in America described inefficiencies in cancer care and the lack of ACP and palliative care for patients with cancer. These broad concerns are especially pertinent for patients enrolled in phase I trials who are vulnerable because of care transitions. Patients may shift from providers or care teams, from a community to an academic center, or even from one state to another. These changes can be anxiety-provoking, burdensome, costly, and confusing. Importantly, these transitions are associated with increases in adverse effects, pain, suffering, and mortality. In addition to these potential risks, participation in phase I trials precludes enrollment in hospice in most settings. As a result, patients and families who enroll in phase I trials could potentially be at risk for a short hospice length of stay (LOS; defined as =3 days). Short hospice LOS is associated with poorer outcomes, including higher rates of emotional distress, inferior symptom management, greater financial toxicity, and worse patient and caregiver experience. Although many factors are not under the control of the phase I team, research suggests physician decision-making, including poor communication and not recognizing the patient as dying, are the most frequent cause of late hospice referral identified by patients’ bereaved family members. Because phase I teams serve as the primary gatekeepers for timely hospice access, ACP and prognostication at the time of disease progression may influence patient and family decision-making.
ACP is a process that involves documenting wishes about values, goals, and preferences. These conversations give patients more control over their cancer care and decrease their risk of receiving unwanted, high-intensity, lower-quality care near EOL. Poor communication regarding patient and family preferences increases the risk for individual harms, including pain and suffering, and family harms, such as psychosocial and financial distress. Good normative and empirical data are needed to better understand post-trial communication and ACP for patients with cancer enrolled in phase I studies. We therefore examined the role of ACP among adults with cancer treated in a phase I clinical trial to determine the prevalence and factors associated with short hospice LOS.
Methods
Study Subjects: In this retrospective study, the medical records of 207 patients enrolled in phase I intervention studies at Johns Hopkins Hospital (JHH) between January 1, 2015, and December 31, 2017, were reviewed in December 2019. The study was approved by the Institutional Review Board. Inclusion criteria comprised a diagnosis of a solid cancer and enrollment in a phase I intervention trial. The primary objective of this study was to identify patient and treatment characteristics associated with a short hospice LOS (=3 days).
Data Collection: Patient demographics and EOL care characteristics were extracted through chart review. Demographic characteristics included age at study entry, sex, race (White, Black/African American, or other), Hispanic ethnicity, cancer type, whether the patient was originally treated at JHH or referred from an outside institution, and number of previous treatments. We also investigated care delivery patterns and abstracted whether patients were referred for palliative care, receipt of additional therapy after disease progression, and healthcare use at EOL. Healthcare use measures included inpatient care in the last 30 days of life, number of hospitalizations in the last 90 days of life, use of skilled nursing facilities, healthcare transitions in the final 3 days of life, intensive care use, and mechanical ventilation during a terminal hospitalization.
We captured physician–patient communication through the electronic health record to extract whether ACP was discussed. All documentation from the time of progression and within the 2 weeks afterward were reviewed. For all patient deaths, documentation of patient goals of care, prognosis, preferred place of death, and EOL planning was captured on a scoring sheet. We also reviewed whether likelihood of response to further treatment or options for alternatives to treatment, such as hospice, were discussed.
For all deaths of patients eligible for study inclusion, we identified a primary diagnosis, a primary oncologist, whether the patient was referred to hospice, an initial referral date to hospice, hospice enrollment date, hospice discharge date, and special circumstances surrounding the referral process (whether the patient declined hospice services or was deemed inappropriate for hospice [not included in hospice LOS] or died between referral and enrollment to hospice services [recorded as LOS 0]). To ensure data accuracy, case report forms were independently checked by a second reviewer.
Statistical Methods: Patient characteristics were summarized with descriptive statistics and frequency distributions. The association between patient characteristics and short hospice LOS were explored with logistic regression analyses and summarized with odds ratios (ORs) and 95% confidence intervals. To identify which patient characteristics were independently associated with short LOS, we conducted a multivariable model building approach using the Fisher exact test and Wilcoxon rank sum test. After examining which variables were associated with short hospice LOS in univariate analyses using a threshold of P<.05, we selected the following variables to include in a full model: referral to palliative care before disease progression, whether the patient was originally treated at JHH or referred from an outside institution, whether the patient remained at JHH after disease progression, whether the goals of care were documented, and whether hospice was discussed after progression. Patient age (<65 vs =65 years), sex, and race (White vs Black or other race) were also included as covariates. P values <.05 were considered statistically significant, and were are 2-sided. Analyses were completed using R version 3.6.0 (R Foundation for Statistical Computing).
Results: Patient demographics are listed in Table 1. Among 207 participants, the median age was 61 years (range, 31–91 years), 48% were women, and 21% were members of racial minority groups. Predominant diagnoses were gastrointestinal (38%), genitourinary (16%), and thoracic/lung cancer (15%). A total of 40.5% of patients enrolled in phase I trials were referred from an outside institution. The median number of treatments before enrollment in a phase I trial was 2 (range, 0–9). At the time of disease progression, 53% had goals of care documented, 47% were previously referred to palliative care, and 41% discussed hospice with their oncologist.
http://dx.doi.org/10.6004/jnccn.2020.7646
Voir la revue «Journal of the national comprehensive cancer network»
Autres numéros de la revue «Journal of the national comprehensive cancer network»
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