Status:
COMPLETED
Informational Meetings for Planning and Coordinating Treatment
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
End of Life
Communication
Eligibility:
All Genders
1-17 years
Phase:
NA
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 clini...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04330833
Start Date
December 8 2020
End Date
July 31 2025
Last Update
December 8 2025
Active Locations (7)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Nemours Children's Health
Wilmington, Delaware, United States, 19803
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202