Informational Meetings for Planning and Coordinating Treatment, The IMPACT Trial
Brain & Spinal Cord Tumor
Brain Tumor
Liver Cancer / Hepatoblastoma
Sarcoma
Solid Tumor
1 Months and older, Male and Female
IUSCC-0705 (primary)
NCI-2021-01462
Summary
This clinical trial investigates parental responses about their information needs, emotions, support resources, appraisal of their child’s symptom management, and their child’s emotions and symptom management. Information from this study may help researchers better understand how to assist parents in coordinating cancer treatment.
Objectives
PRIMARY OBJECTIVE:
I. Determine the efficacy of Communication Plan: Early through End of Life (COMPLETE) versus usual care to foster hospice enrollment percentage (%).
SECONDARY OBJECTIVES:
I. Determine the efficacy of COMPLETE on child outcomes: pain and emotional suffering; and use of high intensity medical interventions at end of life (EOL).
II. Determine the efficacy of COMPLETE on parent outcomes: emotional distress, uncertainty and hope, and satisfaction with healthcare.
EXPLORATORY OBJECTIVE:
I. Examine the extent to which the effects of COMPLETE on child and parent outcomes are mediated through therapeutic alliance and goals-of-care alignment.
OUTLINE: Participants are assigned to Arm A or B based on the arm their pediatric oncology practice has been randomized.
ARM A (Enhanced usual care control): Parents participate in educational group sessions with the registered nurse every 1-4 months for up to 3 sessions where parents choose 2-3 topics to review. Parents and children complete questionnaires over 25-40 minutes every 3-4 months for up to 10 times.
ARM B (COMPLETE intervention): Parents participate in educational group sessions with the registered nurse and physician every 1-4 months for up to 3 sessions with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option. Parents and children complete questionnaires over 25-40 minutes every 1-4 months for up to 10 times.
Eligibility
- CHILDREN: Age 1 month to less than 18 years. Children who were enrolled on study before the age of 18 will continue to be eligible even if they reach 18 years or older while on study
- CHILDREN: Newly diagnosed, defined as being within 16 weeks (112 days) from the time of diagnosis of cancer not including the day of diagnosis [newly diagnosed timing is based on national recommendations for introducing alliative care/end of life [PC/EOL] discussions with parents of children with poor prognosis cancer at diagnosis; or 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
- CHILDREN: Diagnosis of poor prognosis cancer --defined as approximately <25% estimated overall survival, or at the discretion of attending with documentation of appropriate rationale for determination of poor prognosis [PC/EOL interventions are most relevant to parents of children with poor prognoses]
- CHILDREN: Cancer falls into the following diagnosis categories, including but not limited to:
* Central Nervous System Tumor:
** Atypical teratoid rhabdoid tumor
** Glioblastoma multiforme
** Diffuse intrinsic pontine glioma
** Embryonal tumors with multilayered rosettes
** Other high-grade glioma
** Gliomatosis cerebri
* Non-neural solid tumor:
** Metastatic hepatoblastoma (depending on location)
** Metastatic osteosarcoma
** Metastatic Ewing’s sarcoma
** Metastatic rhabdomyosarcoma
** Metastatic desmoplastic small round cell tumor (DSRCT)
** Other metastatic sarcoma/carcinoma – at discretion of attending
** Metastatic unknown primary, rare pathology – at discretion of attending
- CHILDREN: Assent obtained from children >= 7 years old for their own and their parent/guardian’s participation, although this age may differ across performance sites as a result of variations in state law and/or local institutional policy. Children will be asked to complete measures; they are not required to participate in sessions but can attend if parent agrees (Children's Oncology Group [COG] Institutional Review Board [IRB] guideline; COG, 2010)
- PARENT/GUARDIAN: The decision maker(s) for their child (intervention expected to facilitate decisions by parents/legal guardians)
- PARENT/GUARDIAN: >= 18 years of age (likely to be mature enough to make difficult decisions)
- PARENT/GUARDIAN: Biological parent(s), step-parent, or legal guardian (e.g., adoptive parent) (generalizability)
- PARENT/GUARDIAN: Child meets inclusion criteria
- PARENT/GUARDIAN: Informed of child's cancer diagnosis (need to be informed of diagnosis prior to informed consent)
- PARENT/GUARDIAN: Able to read, speak, and understand English (beyond scope of this first efficacy study to deliver and monitor intervention in other languages)
- PARENT/GUARDIAN: Must be willing to be audio recorded during all study sessions
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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