NCT04330833

Informational Meetings for Planning and Coordinating Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2020-12-08
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2020-04-02
• Last updated: 2025-12-08

Locations

7 sites across 1 country: United States