Informational Meetings for Planning and Coordinating Treatment

NCT ID: NCT04330833

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2025-07-31

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.

Conditions

End of Life; Communication; Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Enhanced Usual Care Parent Education

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care Parent Education

Intervention Type: OTHER

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.

Novel Communication Intervention

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.

Group Type: EXPERIMENTAL

Novel Communication Intervention

Intervention Type: OTHER

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.

Interventions

Novel Communication Intervention

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.

Intervention Type: OTHER

Enhanced Usual Care Parent Education

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Susan M Perkins

Professor of Biostatistics and Health Data Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan M Perkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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

Countries

United States

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Related Links

https://www.cancer.gov/publications/patient-education/guide-for-parents

National Cancer Institute Resource: Children with cancer: A parents' guide.

Other Identifiers

R01CA235632-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1904351083

Identifier Type: -

Identifier Source: org_study_id