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

No Placebo-Only Group

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline spiritual well-being at 3 months post-enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Advance Care Document for Children with Rare Diseases

Beck Anxiety Inventory

Days in Palliative Care Prior to Death

+7 more

Secondary study objectives

Brief-Multidimensional Measure of Religion and Spirituality

Family Appraisal of Caregiving Questionnaire for Palliative Care

Other study objectives

Hickman Role Stress Decisional Burden Scale

Quality of Communication Questionnaire

Satisfaction Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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