Informational Meetings for Planning and Coordinating Treatment

Study Overview
=================
Brief Summary
-----------------
This prospective cluster-randomized trial examines the efficacy of a novel communication intervention delivered by trained physician and nurse dyads to parents of children with cancer within the clinicians' practice, to foster alignment of the goals of treatment. The investigators hypothesize that goal alignment will improve quality of life outcomes, in particular for those patients who reach end of life. Findings from the proposed research will provide essential information to promote communication practice standards that can be rapidly translated into practice to improve outcomes for children, particularly those who reach end of life, and parents.

Detailed Description
-----------------
The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.

Official Title
-----------------
Informational Meetings for Planning and Coordinating Treatment

Conditions
-----------------
End of Life, Communication, Cancer Metastatic

Intervention / Treatment
-----------------
* Other: Novel Communication Intervention
* Other: Enhanced Usual Care Parent Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child 1 month to < 18 years Child newly diagnosed, i.e., within 16 weeks (112 days) from time of diagnosis of cancer not including the day of diagnosis, OR Child with relapsed cancer, defined as within 16 weeks (112 days) of first-time relapse/evidence of progression of disease as noted by scan or biopsy after previous diagnosis of cancer. Child provide assent if age ≥ 7 years Poor prognosis, i.e., approximate < 25 % estimated overall survival or at the discretion of the attending AND/OR: Falls into one of the following diagnosis categories, including but not limited to: Atypical teratoid rhabdoid tumor Glioblastoma multiforme Diffuse intrinsic brainstem glioma Embryonal tumors with multilayered rosettes Other high-grade glioma Gliomatosis cerebri Metastatic osteosarcoma Metastatic Ewing sarcoma Metastatic rhabdomyosarcoma Metastatic desmoplastic small round cell tumor (DSRCT) Other metastatic sarcoma/carcinoma-at discretion of attending Metastatic unknown primary- or rare pathology- at discretion of attending Parent(s) legal decision-maker(s) for child Parent(s) ≥18 years of age Parent (s) Informed of child's cancer diagnosis Parent(s) Able to read, speak and understand English Must be willing to be audio recorded during all study sessions. Exclusion Criteria: The parent has neurological/cognitive impairments likely to interfere with study participation; The child ≥ 7 years of age does not provide assent Parent refuses to be audio recorded during sessions.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Usual Care Parent Education<br>Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group. | Other: Enhanced Usual Care Parent Education<br>* The Enhanced Usual Care Parent Education is a series of 3 discussions between the child's primary oncology nurse and the child's parent(s) designed to control for time and attention. These discussions are focused on answering parents' questions and reviewing routine disease and treatment related information. Parents will receive a 1-hour face-to-face session every 3-4 months for a total of 3 sessions. At each session, parents choose 2-3 topics to review with the nurse.<br>|
| Experimental: Novel Communication Intervention<br>Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group. | Other: Novel Communication Intervention<br>* The intervention is a series of 3 guided discussions (using visual aids) between the child's primary oncology physician/nurse team and the child's parent(s) with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25% | We will compare days enrolled in hospice between the Novel Communication Intervention vs Enhanced Usual Care Parent Education groups using a Wilcoxon Rank Sum Test for clustered data. | Within 12 months of death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer. | High intensity medical interventions include: code status order to attempt cardiopulmonary resuscitation, intensive care unit admission within the last 30 days, IV chemotherapy within last 14 days, greater than 2 emergency department visits within last 30 days, more than 1 hospitalization within last 30 days, not on hospice, admitted to hospice less than 3 days prior to death, intubation or cardiac resuscitation within last 30 days, and death in an acute care setting. The difference in the use of high-intensity medical interventions at end of life will be tested between the intervention and enhanced usual care groups with a generalized linear mixed model that accounts for subjects clustering within physician/nurse teams via a random effect. | Within 30 days of death | 
| Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25% | Quality of Life is measured with the Pediatric Quality of Life Inventory- General Module, emotional functioning sub-scale and the Pediatric Quality of Life Cancer Module. Scores range from 0-100, with higher scores indicating better health-related quality of life. Results will be modeled with linear mixed models and compared between the Novel Communication Intervention and Enhanced Usual Care Parent Education groups. | Enrollment, then every 4 months until death or maximum of 4 years | 
| Impact of the Novel Communication Intervention on parental hope. | The Herth Hope Index score ranges from 12-48, with a higher score corresponding to higher levels of hope. Results from the Herth Hope Index are continuous and will be modeled with linear mixed models and compared between the intervention and enhanced usual care groups. | Enrollment, and then every 4 months until death or maximum of 4 years | 
| Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer. | The Parent Experience of Childhood Illness Scale (PECI)-Short Form is used to assess parental adjustment in the primary caregiver of children with chronic illness. It consists of four sub-scales with scores ranging from 0-4. Higher scores indicate poorer coping except for emotional resources, which indicates a higher level of support. | Enrollment, and then every 4 months until death or maximum of 4 years | 
| Impact of Novel Communication Intervention on parental satisfaction with healthcare | The Peds QL HCS (Satisfaction with Healthcare) survey is 24-item scale that measures parent satisfaction with care received from their child's oncology healthcare providers. Subscales assess parental satisfaction with: delivery of care; information received on child's diagnosis and treatments; inclusion of family; technical skills in managing their child's symptoms; and attention to their child's emotional needs. | Enrollment, and then every 4 months until death or maximum of 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interventions, pediatric palliative care