Informational Meetings for Planning and Coordinating Treatment
Completed · Not applicable
Conditions studied: End of Life, Communication, Cancer Metastatic
In brief
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.
Key facts
- Study ID
- NCT04330833
- Run by
- Indiana University
- People needed
- 111
- Starts
- 2020-12-08
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2026-06-01
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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