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

NCT01170000 | Unknown

• 2 other identifiers: 09-0763 BJHR21NR011071
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 4

Brief Summary

A national priority for health care providers is to initiate early communication about palliative and end-of-life care (PC/EOL) for children with a poor prognosis. Communication about prognosis and advanced care planning is critical to empowering parents to make decisions about PC/EOL for their children. A single-group study to refine and pilot test a PC/EOL communication intervention is entitled, Communication Plan: Early through End of Life (COMPLETE). COMPLETE is designed to be delivered during parent meetings and features: (a) a physician-nurse (MD/RN) team approach to PC/EOL communication; (b) printed visual aids and parent resource forms; and (c) hope and non-abandonment messages tailored by a MD/RN team to their communication style and parental preferences for information. During Phase I, an interdisciplinary approach involving nurses, physicians, PC/EOL expert consultants, and bereaved-parent consultants met to develop a standardized protocol and training procedures. During Phase II, this protocol will be evaluated with 24 parents and MD/RN teams. The investigators will evaluate parental outcomes regarding the COMPLETE's influence on: (a) information needs, emotional needs/resources, appraisal of MD/RN information and of symptom management; and (b) parental distress, uncertainty, decision regret, hope, satisfaction with MD/RN communication, and advance care planning over time. Findings from this study address NIH priorities related to: 1) an underserved population (i.e., parents of children with brain tumors); 2) an under-examined ethical concern about early integration of PC/EOL communication for parents of children with poor prognosis; 3) improved communication about PC/EOL among physicians, nurses, and parents; and 4) the potential for changing health care practice.

Conditions

Palliative Care; Communication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Eligibility criteria include parents who are:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Foundation for Barnes-Jewish Hospital: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University School of Nursing

Indianapolis, Indiana, 46212, United States

RECRUITING

SSM Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

RECRUITING

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Verna Ferguson, PhD

  Barnes-Jewish Hospital

  PRINCIPAL INVESTIGATOR

• Joan Haase, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Verna Ferguson, PhD

CONTACT

314-454-8944; vferguson@bjc.org

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

US (4)