Informational Meetings for Planning and Coordinating Treatment (IMPACT)

October 1, 2023 updated by: Susan M Perkins, Indiana University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Susan M Perkins, PhD
  • Phone Number: 317-274-2626
  • Email: sperkin1@iu.edu

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
          • Project Manager
          • Phone Number: 720-777-6353
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Children's Health
        • Contact:
          • Project Manager
          • Phone Number: 302-651-6424
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Active, not recruiting
        • Children's Healthcare of Atlanta
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children at IU Health
        • Contact:
          • Project Manager
          • Phone Number: 317-274-4700
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • Cardinal Glennon Children's Hospital
        • Contact:
          • Site Investigator
          • Phone Number: 314-977-1906
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Children's Cancer Center
        • Contact:
          • Program Manager
          • Phone Number: 713-794-3637
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
          • Project Manager
          • Phone Number: 414-337-0276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Usual Care Parent Education
Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.
Other: Enhanced Usual Care Parent Education
The Enhanced Usual Care Parent Education is a series of 3 discussions between the child's primary oncology nurse and the child's parent(s) designed to control for time and attention. These discussions are focused on answering parents' questions and reviewing routine disease and treatment related information. Parents will receive a 1-hour face-to-face session every 3-4 months for a total of 3 sessions. At each session, parents choose 2-3 topics to review with the nurse.
Experimental: Novel Communication Intervention
Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.
Other: Novel Communication Intervention
The intervention is a series of 3 guided discussions (using visual aids) between the child's primary oncology physician/nurse team and the child's parent(s) with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
Time Frame: Within 12 months of death
We will compare days enrolled in hospice between the Novel Communication Intervention vs Enhanced Usual Care Parent Education groups using a Wilcoxon Rank Sum Test for clustered data.
Within 12 months of death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.
Time Frame: Within 30 days of death

High intensity medical interventions include: code status order to attempt cardiopulmonary resuscitation, intensive care unit admission within the last 30 days, IV chemotherapy within last 14 days, greater than 2 emergency department visits within last 30 days, more than 1 hospitalization within last 30 days, not on hospice, admitted to hospice less than 3 days prior to death, intubation or cardiac resuscitation within last 30 days, and death in an acute care setting.

The difference in the use of high-intensity medical interventions at end of life will be tested between the intervention and enhanced usual care groups with a generalized linear mixed model that accounts for subjects clustering within physician/nurse teams via a random effect.
Within 30 days of death
Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%
Time Frame: Enrollment, then every 4 months until death or maximum of 4 years
Quality of Life is measured with the Pediatric Quality of Life Inventory- General Module, emotional functioning sub-scale and the Pediatric Quality of Life Cancer Module. Scores range from 0-100, with higher scores indicating better health-related quality of life. Results will be modeled with linear mixed models and compared between the Novel Communication Intervention and Enhanced Usual Care Parent Education groups.
Enrollment, then every 4 months until death or maximum of 4 years
Impact of the Novel Communication Intervention on parental hope.
Time Frame: Enrollment, and then every 4 months until death or maximum of 4 years
The Herth Hope Index score ranges from 12-48, with a higher score corresponding to higher levels of hope. Results from the Herth Hope Index are continuous and will be modeled with linear mixed models and compared between the intervention and enhanced usual care groups.
Enrollment, and then every 4 months until death or maximum of 4 years
Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer.
Time Frame: Enrollment, and then every 4 months until death or maximum of 4 years
The Parent Experience of Childhood Illness Scale (PECI)-Short Form is used to assess parental adjustment in the primary caregiver of children with chronic illness. It consists of four sub-scales with scores ranging from 0-4. Higher scores indicate poorer coping except for emotional resources, which indicates a higher level of support.
Enrollment, and then every 4 months until death or maximum of 4 years
Impact of Novel Communication Intervention on parental satisfaction with healthcare
Time Frame: Enrollment, and then every 4 months until death or maximum of 4 years

The Peds QL HCS (Satisfaction with Healthcare) survey is 24-item scale that measures parent satisfaction with care received from their child's oncology healthcare providers. Subscales assess parental satisfaction with:

  1. delivery of care;
  2. information received on child's diagnosis and treatments;
  3. inclusion of family;
  4. technical skills in managing their child's symptoms; and
  5. attention to their child's emotional needs.
Enrollment, and then every 4 months until death or maximum of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Susan M Perkins, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 1, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1904351083
  • R01CA235632-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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