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NCT04330833Completed

Informational Meetings for Planning and Coordinating Treatment

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
111 (actual)
First submitted
19 Feb 2020
Start date
8 Dec 2020
Primary completion date
31 Jul 2025
Lead sponsor
Indiana University
NCT number
NCT04330833

What you commit to

  • Study type: Interventional
  • Participants enrolled: 111
  • From 8 Dec 2020 to the primary completion date, 31 Jul 2025
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • The child ≥ 7 years of age does not provide assent

Other

  • The parent has neurological/cognitive impairments likely to interfere with study participation;
  • Parent refuses to be audio recorded during sessions.

Who the study is looking for

  • 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.

Age in the registry: 1 month to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Healthcare of Atlanta
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
MD Anderson Children's Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Riley Hospital for Children at IU Health
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Children's Hospital of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Cardinal Glennon Children's Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Nemours Children's Health
Coordinator of this site? Confirm its status
WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.