Introducing Pediatric Palliative Care Earlier in Phase 1 Trials

For many children with relapsed or treatment-resistant cancer, enrolling in a phase 1 clinical trial represents hope when standard treatments are no longer working. But it may also come with uncertainty, difficult decisions, and significant physical and emotional challenges for patients and families.

Finding better ways to integrate pediatric palliative care earlier in a child’s illness to provide needed support is a career goal of Andrea Cuviello, MD, a pediatric hematologist-oncologist and palliative medicine specialist at Phoenix Children’s.

Thanks to the 2026 Research Scholar Award from the Advancing the Science of Palliative Care Research Across the Lifespan (ASCENT) Consortium, supported by the National Institutes of Health (NIH), Dr. Cuviello is one step closer to reaching that goal. Her two-year project, selected through a competitive national application process, will study whether integrating pediatric palliative care earlier in the phase 1 clinical trial process can improve the experience for children with cancer and their families.

“Despite evidence showing the benefits of pediatric palliative care, it’s not used consistently in pediatric oncology care, particularly in the setting of early-phase clinical trials,” Dr. Cuviello said. “My overarching career goal is to improve the implementation of early pediatric palliative care integration for children with serious illness and their families.”

Meeting Families Earlier in Their Cancer Journey

Although cure rates continue to improve, 1 in 5 children with cancer still die from their disease. Many advances in childhood cancer treatment come through clinical trials, and phase 1 studies help determine whether promising new therapies are safe. These trials can offer hope when no other treatment options remain, but they may also bring treatment-related side effects, uncertainty and emotional distress for patients and families.

Pediatric palliative care is designed to ease physical, psychological, emotional and spiritual suffering while improving communication, shared decision-making and quality of life. Yet not every family learns of these services in time to benefit from them.

“Earlier integration of pediatric palliative care empowers families by enhancing their understanding of complex illnesses and facilitating shared medical decision-making,” Dr. Cuviello said. “It’s important to ensure families are supported and know what to expect during phase 1 clinical trials.”

She added: “Through transparent communication and trusted therapeutic relationships, pediatric palliative care helps parents weigh options and prioritize the goals that best serve their child’s unique needs.”

A New Approach to Palliative Care Integration

Dr. Cuviello’s study will evaluate whether introducing a pediatric palliative care consultation during eligibility screening for phase 1 clinical trials is feasible, acceptable and beneficial for patients and families. Rather than waiting until later in a child’s illness, the model uses a standard point in the care journey to connect families with additional support.

“The main intervention we’re testing is including a palliative care consult during the eligibility screening for patients considering a phase 1 pediatric oncology trial,” Dr. Cuviello said.

Researchers also plan to gather feedback from patients, caregivers and oncologists to help refine the model and guide future studies. The goal is to better understand how earlier palliative care integration can improve the experience of phase 1 clinical trials for patients and their families.

Building the Evidence for Earlier Integration

The project will evaluate recruitment, enrollment, adherence and completion of study activities over the two-year grant period. More importantly, Dr. Cuviello hopes the study will generate the information needed to design larger, multicenter trials evaluating the effects of earlier palliative care on patient and family outcomes.

“The ASCENT Research Scholar Award provides me time to execute this study, and it also provides me with opportunities to expand my skills as a clinician scientist,” she said. “Together, the findings from this study and my additional training in implementation science will position me well for continuing to find creative, successful and impactful ways to integrate palliative care into standard oncology care. I very much view this award as a building block on my way to continued NIH funding support with future R-level grants.”

Looking Ahead

If successful, the research could provide a framework for pediatric oncology centers across the country to introduce palliative care during eligibility screening for phase 1 clinical trials. Because eligibility screening is a consistent point in care across institutions, the model has the potential to be implemented broadly and help establish earlier palliative care integration as a standard part of pediatric oncology practice.

“This model could easily be extrapolated to all pediatric oncology centers offering phase 1 clinical trials,” Dr. Cuviello said.

Refer a Patient or Request a Consult

Contact Phoenix Children’s Palliative Care team to discuss earlier palliative care involvement for your pediatric oncology patients – particularly those with high-risk disease, relapsed or refractory cancer, metastatic disease, bone marrow transplant candidates or patients being considered for phase 1 clinical trials.

Initial findings are expected in early to mid-2028 and will be shared, upon ASCENT approval OR upon ASCENT’s publication of the study, at the AAHPM, ASPHO, and SIOP annual meetings. To learn more about Phoenix Children's Palliative Care team’s standardized referral criteria – used across oncology, the Pediatric Intensive Care Unit (PICU) and the Neonatal Intensive Care Unit (NICU) – contact us at (602) 933-7255.

This work is supported by the ASCENT Consortium 2026 Research Scholar Award (FY2026-R009), funded  by the National Institute On Aging of the National Institutes of Health under Award Number U54AG093230.

Disclaimer: Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under Award Number U54AG093230. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.