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Behavioral Intervention
Family-Centered Palliative Care for Children with Rare Diseases (FACE-Rare Trial)
N/A
Waitlist Available
Led By Maureen E Lyon, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline anxiety at 3 months post-enrollment
Awards & highlights
FACE-Rare Trial Summary
This trialseeks to improve palliative care needs of families caring for children with ultra-rare diseases, by piloting a new assessment and intervention.
Who is the study for?
This trial is for English-speaking caregivers of children with ultra-rare diseases, aged between 1 and less than 18 years old. The child must not be in intensive care, under end-of-life orders, or unable to make decisions about their care.Check my eligibility
What is being tested?
The FACE pACP Intervention is being tested to see if it helps family caregivers discuss future medical choices for their children with rare diseases. It's a pilot study using new methods to assess palliative care needs.See study design
What are the potential side effects?
Since this intervention involves discussions and planning rather than medication, traditional physical side effects are not expected; however, emotional or psychological stress may occur.
FACE-Rare Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline spiritual well-being at 3 months post-enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline spiritual well-being at 3 months post-enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Advance Care Document for Children with Rare Diseases
Beck Anxiety Inventory
Days in Palliative Care Prior to Death
+7 moreSecondary outcome measures
Brief-Multidimensional Measure of Religion and Spirituality
Family Appraisal of Caregiving Questionnaire for Palliative Care
Other outcome measures
Hickman Role Stress Decisional Burden Scale
Quality of Communication Questionnaire
Satisfaction Questionnaire
FACE-Rare Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FACE-Rare InterventionExperimental Treatment1 Intervention
FACE-Rare is a behavioral intervention that combines the CSNAT Pediatric Approach and the Respecting Choices® Next Steps ACP over 3 sessions.
Sessions 1&2: CSNAT is an evidence-based process of family caregiver assessment and support in specialized medical (palliative) care. The CSNAT tool is structured around 16 categories of family caregiver support. With the goal to decrease caregiver burden, this process consists of 5 stages wherein a nurse or practitioner works with the caregiver to create a shared support plan for the child.
Session 3: Respecting Choices® Next Steps- This advanced care planning (pACP) conversation engages families in a process for how to make future medical decisions consistent with their goals and values. The interview is structured in 6 stages to achieve 2 main goals: to facilitate conversations with the family about their child's medical condition, history, fears, values, beliefs, and hopes; and to set the stage for the family's future healthcare decisions.
Group II: Treatment-as-Usual (TAU) ControlActive Control1 Intervention
To minimize the burden to families, we have chosen a Treatment-as-Usual (TAU) comparison condition, where patients will receive their normal standard of care. Both study arms will receive palliative (specialized medical) care information at enrollment and complete questionnaires before and after the intervention or TAU period. Current practice for minors with life-limiting illnesses is to defer initial discussions of advanced care planning (pACP) until a medical crisis, so this is what the TAU control arm condition will consist of.
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Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,376,334 Total Patients Enrolled
Children's National Research InstituteLead Sponsor
210 Previous Clinical Trials
207,709 Total Patients Enrolled
Respecting ChoicesUNKNOWN
1 Previous Clinical Trials
778 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have an order that says you cannot be resuscitated or allowed to pass away naturally.I am 18 years old or older.You can speak and understand English.You are not experiencing significant delays in your physical, mental, or emotional development.You are the legal guardian and caregiver for a child.I am between 1 and 17 years old.You have a medical condition that is considered rare, as defined in the Human Subjects guidelines.You are not currently in the hospital's intensive care unit.This information is incomplete.I cannot make decisions about my end-of-life care.
Research Study Groups:
This trial has the following groups:- Group 1: FACE-Rare Intervention
- Group 2: Treatment-as-Usual (TAU) Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the requirements to enroll in this observational trial?
"This clinical trial has room for 60 participants suffering from a rare illness, aged between one year and 99 years. The minimum age requirement is 1 year old while the maximum is 18 years of age if they are not capable of participating in their own end-of-life care decisions. Additionally, all potential candidates must be without Do Not Resuscitate or Allow Natural Death Orders and cannot currently reside within an Intensive Care Unit."
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Is there an age limit that precludes older individuals from participating in this clinical research?
"The legal minimum age of consent for this study is 1 year, while the maximum permissible age is 99."
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What is the upper limit of enrollees for this research study?
"Indeed, the clinicaltrials.gov website states that this research trial is still actively seeking patients. First posted on July 6th 2021 and last modified November 14th 2022, it requires 60 participants from a single medical centre."
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Are there any vacancies for individuals to participate in this clinical research?
"Affirmative. The information on clinicaltrials.gov indicates that this experiment is currently seeking volunteers, with the initial posting occurring on June 7th 2021 and most recent modifications documented November 14th 2022. A total of 60 participants are sought from a single site for inclusion in this trial."
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