Timely End-of-Life Communication to Parents of Children With Brain Tumors

The target sample size is 24 parents of 12 children diagnosed with a brain tumor. Our sample size is sufficient to complete descriptive analyses of Aims 2 and 3, and adequate precision for the estimation of effect sizes and preliminary tests of single-arm efficacy in Aim 4.1. This study is powered for adequate estimation of effect sizes, not for efficacy; that is, the study is powered to appropriately detect large effect sizes with lower power for medium effect sizes. If 10% or fewer participants withdraw after COMPLETE Session 1, we will be able to collect data from about 22 parents at least once. Twenty-two parents will provide 61% power for detecting a difference of 0.5 times standard deviation for a two-sided paired t-test with alpha of .05. The same test would have 70% power to detect a difference of .55 standard deviation. This approach is typical and justifiable in pilot feasibility studies to achieve 80% power for detecting only large effect sizes.

Inclusion Criteria:

• Eligibility criteria include parents who are:
• 18 years of age or older;
• the primary decision makers (i.e., single parent or couple-dyad) for their child (birth to 18 years of age);
• the biological parents, step-parents, or legal guardians (e.g., adoptive parent);
• single or married;
• informed that their child is diagnosed with a brain tumor with a poor prognosis as determined by the primary neuro-oncologist (e.g., glioblastoma multiforme, PNET, WHO grade 3/4 brain tumor, or metastatic medulloblastoma); [3, 33, 38, 41, 42, 175]
• able to read, speak, and understand English.
• Our rationale for these criteria is to include: (a) parents of children who are at high risk of not receiving timely PC/EOL and b) parents who are likely to be mature enough to make difficult decisions on their own. In addition, we recognize the importance of providing sensitive PC/EOL communication to all parents; however, it is beyond the scope of the R21 mechanism to develop scripts in other languages.

Exclusion Criteria:

• Parents will be excluded from the study if:
• the child's brain tumor has a good prognosis (e.g., a non-metastatic medulloblastoma);
• the child has been treated previously for another type of cancer;
• the parents have neurological and/or cognitive impairments, as reported by the site MD/RN team, preventing them from understanding the treatment options and completing the questionnaires;
• either parent in a decision-making couple (i.e., dyad) declines consent.