Recruiting

Observational Study

Sponsor:

The Foundation for Barnes-Jewish Hospital

Code:

NCT01170000

Conditions

Palliative Care

Communication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT01170000

Start date

Sep, 2009

Status verified date

Jun, 2011

Completion date

Aug, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

6 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Verna Ferguson, PhD

314-454-8944vferguson@bjc.org

Locations

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Joan Haase, PhD

Indiana University School of Nursing

Recruiting

Indianapolis, Indiana, United States, 46212

Contacts

Joan Haase, PhD

314-274-2982

Principal Investigator:

Joan Haase, PhD

SSM Cardinal Glennon Children's Hospital

Recruiting

St. Louis, Missouri, United States, 63104

Contacts

Karen Gauvain, MD

314-577-5638kgauvain@slu.edu

Principal Investigator:

Karen Gauvain, MD

Barnes-Jewish Hospital

Recruiting

St. Louis, Missouri, United States, 63110

Contacts

Verna Ferguson, PhD

314-454-8944vferguson@bjc.org

Principal Investigator:

Verna Ferguson, PhD

More Information

Sponsor

The Foundation for Barnes-Jewish Hospital

Last update posted

Jun 28, 2011

Last verified

Jun, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Foundation for Barnes-Jewish Hospital on 2011-06-28.