Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials

NCT07696065 | Recruiting Early Phase 1

• 2 other identifiers: 26-101U54AG093230
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Although cure rates continue to rise, one in five children with cancer still die from their disease, so new therapies are urgently needed. Most advances in childhood cancer treatments have originated through clinical trial research and new therapies must be tested in early phase clinical trials. Phase 1 clinical trials are designed to focus mainly on determining whether a drug is safe, and less on how well it cures a disease. These trials may offer patients and families hope when no other options are available to treat their cancer. However, patients in these trials may also experience treatment-related side effects and earlier death. Patients and families enrolled in phase 1 clinical trials often experience increased levels of distress. This distress may result from physical effects of the disease or treatments, or from worry, sadness, or confusion when making difficult decisions related to care or end-of-life. Pediatric palliative care (PPC) is a field that aims to ease physical, psychological, emotional, and spiritual suffering and may be beneficial to patients and families enrolling in phase 1 clinical trials. Over the past decade, PPC has been shown to improve quality of life, patient and family healthcare understanding and satisfaction, communication, shared-medical decision making, advanced care planning, and healthcare cost savings. Despite evidence showing the benefits of PPC, it is not used consistently in pediatric oncology care, particularly in the setting of early phase clinical trials. Including PPC experts is a proven way to improve access to specialty care for vulnerable populations. In this application, investigators propose a study to test the feasibility, acceptability, and potential impact of including PPC consultation for pediatric cancer patients and their families during their enrollment in phase 1 clinical trials.

Conditions

Quality of Life Outcomes

Keywords

pediatric; palliative care; phase 1 oncology trials

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Feasibility will be defined as a mean FIM score of ≥ 3 (coded 1-5) for \> 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients/caregivers will assent/consent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.

  2 years

• Acceptability

  Acceptability will be defined as a mean AIM score of ≥ 3 (coded 1-5) for \> 70% of caregivers and oncology providers. Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.

  two years

Secondary Outcomes (2)

• Barriers and Facilitators to Palliative Care Integration

  two years

• Impact on quality of life

  two years

Study Arms (1)

Pediatric Palliative Care Consultation

EXPERIMENTAL

Formal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial. Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.

Behavioral: Pediatric Palliative Care Consultation

Interventions

Pediatric Palliative Care Consultation BEHAVIORAL

Formal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial. Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.

Pediatric Palliative Care Consultation

Eligibility Criteria

• Age: 0 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients (aged 0-25 years) diagnosed with cancer and undergoing evaluation for enrollment in a phase 1 trial, their caregivers, as well as their primary treating oncologist are eligible for study participation.

You may not qualify if:

• Previous palliative care exposure

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

National Institutes of Health

Bethesda, Maryland, 20814, United States

NOT YET RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

NOT YET RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 10, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): January 14, 2028
• Study Completion (Estimated): June 14, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)