Informational Meetings for Planning and Coordinating Treatment

Indiana University111 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

111

Conditions

End of Life

Interventions

Novel Communication InterventionOTHER

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.

Enhanced Usual Care Parent EducationOTHER

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (7)

Children's Hospital Colorado

Aurora, Colorado, United States

Nemours Children's Health

Wilmington, Delaware, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

MD Anderson Children's Cancer Center

Houston, Texas, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Within 12 months of death

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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: 1. delivery of care; 2. information received on child's diagnosis and treatments; 3. inclusion of family; 4. technical skills in managing their child's symptoms; and 5. attention to their child's emotional needs.

Time frame: Enrollment, and then every 4 months until death or maximum of 4 years