Informational Meetings for Planning and Coordinating Treatment (IMPACT)

Indiana University

Status: Completed

Conditions: Communication; Cancer Metastatic; End of Life

Treatments: Other: Enhanced Usual Care Parent Education; Other: Novel Communication Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04330833

1904351083

R01CA235632-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.

Enrollment: 111 patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

Enhanced Usual Care Parent Education

Active Comparator group

Description:

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.

Treatment:

Other: Enhanced Usual Care Parent Education

Novel Communication Intervention

Experimental group

Description:

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.

Treatment:

Other: Novel Communication Intervention