End-of-Life Characteristics Associated With Short Hospice Length of Stay for Patients With Solid Tumors Enrolled in Phase I Clinical Trials

Abstract

Background: Patients participating in phase I trials represent a population with advanced cancer and symptoms, with quality-of-life implications arising from both disease and treatment. Transitions to end-of-life care for these patients have received little attention. Good empirical data are needed to better understand the role of advance care planning and palliative care during phase I trial transitions. We investigated how physician–patient communication at the time of disease progression, patient characteristics, and patterns of care were associated with end-of-life care. Methods: We conducted a retrospective chart review of all patients with solid tumors enrolled in phase I trials at a comprehensive cancer center from January 2015 to December 2017. We captured physician–patient communication during disease progression. Among patients who died, we assessed palliative care referral, advance care planning, place of death, healthcare use in the final month of life, hospice enrollment, and hospice length of stay (LOS). Factors independently associated with a short hospice LOS (defined as ≤3 days) were estimated from a multivariable model building approach. Results: Among 207 participants enrolled in phase I intervention studies at Johns Hopkins Hospital, the median age was 61 years (range, 31–91 years), 48% were women, 21% were members of racial minority groups, and 41.5% were referred from an outside institution. 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. A total of 82% of decedents died within 1 year of study enrollment, and 85% enrolled in hospice. Among the 147 participants who enrolled in hospice, 22 (15%) had a short LOS (≤3 days). Factors independently associated with an increased risk of short hospice LOS in the multivariable model included age >65 years (odds ratio [OR], 1.12; 95% CI, 1.01–1.24; P=.04), whereas remaining at the same institution (OR, 0.72; 95% CI, 0.65–0.80; P<.001) and referral to palliative care before progression (OR, 0.83; 95% CI, 0.75–0.92; P<.001) were associated with a decreased risk of short hospice LOS. Conclusions: Reported data support the benefit of palliative care for patients in phase I trials and the risks associated with healthcare transitions for all patients, particularly older adults, regardless of care received. Leaving a clinical trial is a time when clear communication is paramount. Phase I studies will continue to be vital in advancing cancer treatment. It is equally important to advance the support provided to patients who transition off these trials.

Palliative Care for Patients With Cancer: ASCO Guideline Update

“…[2][3][4]65,66 Phase I cancer clinical trial participants may struggle to cope with the uncertainty regarding their future and the many symptoms associated with their cancer and prior treatment. [5][6][7][8]32,[67][68][69] Participants are at risk for many symptom concerns, 1,9,10,64,70,71 with a symptom burden that may include fatigue, sleep disturbance, nausea, decreased appetite, anxiety, pain, and bowel changes. 7,11,12,62,68,72 Investigators recently reported (note: study not from the systematic review) patient-reported outcomes with many symptoms, including bloating, constipation, frequent urination, dry mouth, shortness of breath, anxiety, depression, and problems with memory and concentration affecting nearly 40% of the patients that they rated as severe or very severe.…”

“…Study authors have also reported findings that few phase I clinical trial participants complete advance care planning and/or receive palliative care or hospice care at the end of life. 5,8,32,69,73 In a recent study of phase I clinical trial participants, only 39% completed an advanced directive, 35% had a designated health care proxy, and 37% enrolled in hospice despite a 10.1-month median survival from enrollment. 5 Another study demonstrated that 47% had received a palliative care consult, and only 53% had a documented goals-of-care discussion.…”

“…5 Another study demonstrated that 47% had received a palliative care consult, and only 53% had a documented goals-of-care discussion. 8,69 The phase I clinical trial population represents a vulnerable, often underserved population with serious illness, limited life expectancy, and minimal research to understand and address their unmet needs. 1,8,10,64,69,70,73 Efforts to address the care needs of phase I clinical trial participants are critically important and greatly needed.…”

“…8,69 The phase I clinical trial population represents a vulnerable, often underserved population with serious illness, limited life expectancy, and minimal research to understand and address their unmet needs. 1,8,10,64,69,70,73 Efforts to address the care needs of phase I clinical trial participants are critically important and greatly needed. Collectively, phase I clinical trial participants represent a population particularly in need of ongoing research to help assess, address, and manage their distinctive clinical care needs and enhance QOL.…”