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Informational Meetings for Planning and Coordinating Treatment, The IMPACT Trial

Status
Active
Cancer Type
Brain & Spinal Cord Tumor
Sarcoma
Solid Tumor
Trial Phase
Eligibility
1 Months and older, Male and Female
Study Type
Supportive care
NCT ID
NCT04330833
Protocol IDs
IUSCC-0705 (primary)
NCI-2021-01462
Study Sponsor
Indiana University/Melvin and Bren Simon Cancer Center

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 over 1 hour every 3-4 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 over 1 hour every 3-4 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 3-4 months for up to 10 times.

Eligibility

  1. CHILDREN: Age 1 month to less than 18 years
  2. CHILDREN: Newly diagnosed (i.e., within 2-8 weeks); (Newly diagnosed timing is based on national recommendations for introducing palliative care/end of life [PC/EOL] discussions with parents of children with poor prognosis cancer at diagnosis)
  3. CHILDREN: Diagnosis of poor prognosis cancer -- approximately < 25% estimated overall survival, at discretion of attending (PC/EOL interventions are most relevant to parents of children with poor prognoses)
  4. 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 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
  5. 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)
  6. PARENT/GUARDIAN: The decision maker(s) for their child (intervention expected to facilitate decisions by parents/legal guardians)
  7. PARENT/GUARDIAN: >= 18 years of age (likely to be mature enough to make difficult decisions)
  8. PARENT/GUARDIAN: Biological parent(s), step-parent, or legal guardian (e.g., adoptive parent) (generalizability)
  9. PARENT/GUARDIAN: Child meets inclusion criteria
  10. PARENT/GUARDIAN: Informed of child's cancer diagnosis (need to be informed of diagnosis prior to informed consent)
  11. PARENT/GUARDIAN: Able to read, speak, and understand English (beyond scope of this first efficacy study to deliver and monitor intervention in other languages)
  12. PARENT/GUARDIAN: Must be willing to be audio recorded during 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... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.