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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170000
Recruitment Status : Unknown
Verified June 2011 by Barnes-Jewish Hospital.
Recruitment status was:  Recruiting
First Posted : July 27, 2010
Last Update Posted : June 28, 2011
National Institute of Nursing Research (NINR)
Information provided by:
Barnes-Jewish Hospital

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.

Condition or disease
Palliative Care Communication

Detailed Description:

Physicians and nurses (MDs/ RNs) struggle to communicate effectively about palliative and end-of-life (PC/EOL) care with parents when their child's prognosis is poor, and rarely collaborate as a team in this difficult process. The aim of this study was to develop and evaluate training strategies for MD/RN dyads to collaboratively deliver a PC/EOL communication intervention called, Communication Plan: Early through End of Life (COMPLETE), to 24 parents of children with brain tumors. During Phase I, training strategies were based on principles from a Relationship Centered Care perspective. The training was delivered to 3 pediatric neuro-oncologists and 5 oncology nurses by a team of parent advisors and a team of expert consultants (i.e., medical ethics, communication, and PC/EOL). Our 2-day training included 4 modules: family assessment, goal directed treatment planning, anticipatory guidance, and staff communication and follow-up. Each module included: didactic content, small group reflective sessions, and communication skills practice with bereaved parent. Evaluations included dichotomous (agree/disagree) ratings and qualitative comments on didactic content, small group reflection, and skills practice for each module. Helpful aspects of our training strategies included: parent advisers' insights, emotional presence, emphasis on hope and non-abandonment messages, written materials to facilitate PC/EOL communication, and a team approach. For this presentation we will discuss insights gained regarding use of a parent advisory panel, strategies to help the MD/RN dyads feel comfortable working as a team to communicate with parents, and ways to improve training procedures and our intervention.

Pediatric oncology physicians and nurses found PC/EOL care communication training strategies and content as helpful and useful. During Phase II of our study, our PC/EOL care communication intervention is planned to be implemented and evaluated with 24 enrolled parents. If effective, this intervention will facilitate integration of quality PC care practices into the care of children with brain tumors.

Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Timely End-of-Life Communication to Parents of Children With Brain Tumors
Study Start Date : September 2009
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01170000

Contact: Verna Ferguson, PhD 314-454-8944

United States, Indiana
Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Joan Haase, PhD         
Principal Investigator: Joan Haase, PhD         
Indiana University School of Nursing Recruiting
Indianapolis, Indiana, United States, 46212
Contact: Joan Haase, PhD    314-274-2982      
Principal Investigator: Joan Haase, PhD         
United States, Missouri
SSM Cardinal Glennon Children's Hospital Recruiting
St. Louis, Missouri, United States, 63104
Contact: Karen Gauvain, MD    314-577-5638   
Principal Investigator: Karen Gauvain, MD         
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Verna Ferguson, PhD    314-454-8944   
Principal Investigator: Verna Ferguson, PhD         
Sponsors and Collaborators
Barnes-Jewish Hospital
National Institute of Nursing Research (NINR)
Principal Investigator: Verna Ferguson, PhD Barnes-Jewish Hospital
Principal Investigator: Joan Haase, PhD Indiana University

Responsible Party: Verna Ferguson - Principal Investigator, Barnes-Jewish Hospital Identifier: NCT01170000     History of Changes
Other Study ID Numbers: 09-0763 BJH
R21NR011071 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases