Palliative CareNCT01170000
Timely End-of-Life Communication to Parents of Children With Brain Tumors
An observational study of Palliative Care and Communication, run by The Foundation for Barnes-Jewish Hospital at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Communication
- How many people
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2009to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
Joan Haase, PhD
Joan Haase, PhD
- Recruiting
Indiana University School of Nursing
Indianapolis, Indiana, 46212
Joan Haase, PhD, 314-274-2982
Joan Haase, PhD
- Recruiting
SSM Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Karen Gauvain, MD, 314-577-5638, kgauvain@slu.edu
Karen Gauvain, MD
- Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Verna Ferguson, PhD, 314-454-8944, vferguson@bjc.org
Verna Ferguson, PhD
About this study
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.
Read the 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.
- Conditions
- Palliative Care, Communication
- Medical subject headings
- Communication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Foundation for Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Verna Ferguson, PhD, Principal investigator, Barnes-Jewish HospitalJoan Haase, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170000
- Sponsor's protocol ID
- 09-0763 BJH
- Other IDs
- R21NR011071
- Status last verified
- Jun 2011
- First submitted
- 26 Jul 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely End-of-Life Communication to Parents of Children With Brain Tumors
- ClinicalTrials.gov ID
- NCT01170000
- Acronym / sponsor ID
- 09-0763 BJH
- Conditions
- Palliative Care, Communication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- The Foundation for Barnes-Jewish HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verna Ferguson, PhD principal investigator
Barnes-Jewish Hospital
Joan Haase, PhD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Communication, run by The Foundation for Barnes-Jewish Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verna Ferguson, PhD (314-454-8944, vferguson@bjc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.