Clinical trial NCT04330833: Informational Meetings for Planning and Coordinating Treatment
Official title: Informational Meetings for Planning and Coordinating Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End of Life
Communication
Cancer Metastatic
Keywords: interventions
pediatric palliative care
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-02
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
timeFrame: Within 12 months of death
Secondary outcomes:
measure: Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.
timeFrame: Within 30 days of death
measure: Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%
timeFrame: Enrollment, then every 4 months until death or maximum of 4 years
measure: Impact of the Novel Communication Intervention on parental hope.
timeFrame: Enrollment, and then every 4 months until death or maximum of 4 years
measure: Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer.
timeFrame: Enrollment, and then every 4 months until death or maximum of 4 years
measure: Impact of Novel Communication Intervention on parental satisfaction with healthcare
timeFrame: Enrollment, and then every 4 months until death or maximum of 4 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
city: St. Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Houston
country: United States
facility: MD Anderson Children's Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Indiana University
name: Susan M Perkins, PhD
role: PRINCIPAL_INVESTIGATOR
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