Clinical trial · Interventional
Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life Outcomes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pediatric Palliative Care Consultation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pediatric Palliative Care Consultation
- description
- 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.
- interventionNames
- Behavioral: Pediatric Palliative Care Consultation
Primary outcomes (2)
- measure
- Feasibility
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Previous palliative care exposure
References
Publications (0)
Data not yet available