RNQualitativeSeminars in oncology nursing2021

Parents' Insights into Pediatric Oncology Phase I Clinical Trials: Experiences from Their Child's Participation.

Stacey Crane, James M Croop, Jill Lee and 2 others

PMID 34148742

WHAT IT FOUND

Parents of children in pediatric oncology phase I trials described burdens from confusing trial information, travel for second opinions, extra research blood draws, rigid protocol rules, and daily oral medicines.

Key findings

01Parents identified five challenging aspects of phase I trial participation: learning about trials, being referred to another institution, research-only procedures, adhering to trial requirements, and oral medications.

02Research-only blood draws and procedures were burdensome, especially during follow-up after therapy stopped, and parents were more willing to do them if combined with scheduled medical care.

03Oral trial medications were difficult because children disliked oral medications, had trouble swallowing pills, and faced food and drink restrictions around doses.

STILL TO COME

How it was doneWhat they foundWhat it means for RNs

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What it does not show

The study included only 11 parents of 10 children, so it captures a narrow set of experiences rather than a broad picture of all families. Most participants were white (100%), non-Hispanic (90.9%), female (81.8%), and well educated, with 45.5% holding a graduate or professional degree, so the findings may not reflect families with different backgrounds or health literacy. Response rates at the two medical centers were 35.3% (6 of 17) and 33.3% (3 of 9), and parents of children who died within the previous 60 days were excluded, raising concern that participating parents may differ from those who did not. Interviews were retrospective, so parents' memories and feelings may have changed over time. The study did not test any nursing, educational, or logistical strategy, so it cannot show that these suggested actions would reduce burden.

Declared interests

The authors declare no financial or other conflicts of interest. The declaration also notes that Dr. Croop, Ms. Lee, and Ms. Walski are actively involved in conducting and managing phase I clinical trials through the Children's Oncology Group Pediatric Early Phase Clinical Trial Network.

The easy way to misread this

Do not conclude that phase I trial participation was overall harmful or that a specific nurse-led strategy would reduce burden. The study described 11 parents' retrospective experiences and did not test interventions or compare clinical outcomes.

Read it on PubMed →