A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials

Abstract

Purpose Patients enrolled in Phase 1 clinical trials have typically exhausted standard therapies and often are choosing between a clinical trial and hospice care. Significant symptom burden can result in early trial discontinuation and confound trial outcomes. This study aimed to examine differences in study duration, symptom burden, adverse events (AE), and quality of life (QOL) between those receiving structured palliative care versus usual supportive care. Patients and methods Sixty‐eight patients enrolled in phase 1 clinical trials and 39 of their CGs were randomly assigned to receive structured palliative care or usual supportive care. Patient QOL was measured monthly using the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale. The Quality of Life in Life‐Threatening Illness–Family Care Version and Caregiver Reaction Assessment were used for CGs. AEs and use of palliative care resources were compared between arms. Results Mean duration of the phase 1 study was 142 days in the palliative care arm versus 116 days in the usual care arm (p = 0.55). Although not statistically significant, patients in the palliative care arm experienced fewer AEs and better QOL, as did their CGs, compared to those receiving usual care. Conclusions Phase 1 patients and their CGs have physical and psychosocial needs warranting palliative care services. Results suggest that structured palliative care is associated with the increased duration of the study and improved patient and CG QOL.

PALLIA 10 score in phase I cancer studies

“…Finally, 23% and 26% of the patients in C1 and C2 died 3 months after discontinuation of the study, but only few were addressed to our palliative care team, which highlight the need for a better evaluation of the patients. While our study did not report any data regarding change in quality of life, a randomised control trial on 68 patients included in early clinical trials showed fewer adverse events and better quality of life for patients receiving palliative care than those in the control group 23…”

Family caregivers support their patient's decision to participate in a phase 1 clinical trial: Weighing the pros and cons, bearing the costs

“…There is also an increased recognition of the benefits of implementing palliative care for patients as they undergo phase 1 trials, despite their previous ineligibility as a result of receiving disease-directed therapy. 19,[27][28][29][30] Early engagement of palliative care might offset burden of care for caregivers by helping with the aggressive management of patient symptoms while addressing goals of care in the context of a lifelimiting illness. 30 This study reveals that caregivers are compelled to unequivocally support patients' decisions to pursue phase 1 trials for advanced cancer out of a sense of urgency to achieve disease stabilization and in order to endorse patient autonomy.…”

“…19,[27][28][29][30] Early engagement of palliative care might offset burden of care for caregivers by helping with the aggressive management of patient symptoms while addressing goals of care in the context of a lifelimiting illness. 30 This study reveals that caregivers are compelled to unequivocally support patients' decisions to pursue phase 1 trials for advanced cancer out of a sense of urgency to achieve disease stabilization and in order to endorse patient autonomy. To protect patient autonomy, they withhold their opinions about the trial to avoid influencing the patient's decision.…”

“…It is suggested that caregiver‐specific information sheets be developed to guide the caregivers in their new roles. There is also an increased recognition of the benefits of implementing palliative care for patients as they undergo phase 1 trials, despite their previous ineligibility as a result of receiving disease‐directed therapy 19,27–30 . Early engagement of palliative care might offset burden of care for caregivers by helping with the aggressive management of patient symptoms while addressing goals of care in the context of a life‐limiting illness 30 …”

The impact of clinical trial enrollment on specialty palliative care utilization in pediatric patients with high‐grade gliomas

“…These discussions represent an opportunity to introduce specialty PC services when describing the potential for symptom burden, limited life expectancy, and need for psychosocial support. Furthermore, a randomized controlled study of patients actively enrolled in phase 1 clinical trials comparing concurrent structured PC and usual supportive care found that patients with structured PC had fewer adverse events and better quality of life, though not statistically significant 20. As such, it may be worth considering a specialty PC referral be made for a patient and their family at the time of therapeutic clinical trial enrollments, especially in the setting of a high-risk cancer diagnosis.Further studies evaluating the causative factors leading to missed opportunities for early PC involvement are warranted, though our study suggests that clinical trial participation may not contribute to the timing of PC involvement.…”