Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
This study is looking at how well integrating Palliative Care Consultation (PPC) works for children and young adults (ages 0-25) with cancer who are considering joining a Phase 1 clinical trial. Phase 1 trials test new treatments mainly to see if they are safe. We want to see if having a specialized PPC doctor involved early on is practical and helpful for patients, their families, and their oncologists. The study aims to enroll 30 participants and is currently unclear about its recruitment status. Success will be measured by how feasible (practical) and acceptable this approach is over two years.
- Study design
- This is a single-arm study, meaning all participants will receive the same intervention. It aims to enroll 30 participants.
- What's involved
- You would have a formal PPC consultation during the eligibility screening for the Phase 1 trial, followed by standard PPC visits every 2-4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess feasibility and acceptability over two years.
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Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility2 years
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.
- Acceptabilitytwo years
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.