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Informational Meetings for Planning and Coordinating Treatment (IMPACT)

Primary Purpose

End of Life, Communication, Cancer Metastatic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel Communication Intervention
Enhanced Usual Care Parent Education
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End of Life focused on measuring interventions, pediatric palliative care

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital ColoradoRecruiting
  • Nemours Children's HealthRecruiting
  • Children's Healthcare of Atlanta
  • Riley Hospital for Children at IU HealthRecruiting
  • Cardinal Glennon Children's HospitalRecruiting
  • MD Anderson Children's Cancer CenterRecruiting
  • Children's Hospital of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Usual Care Parent Education

Novel Communication Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
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.

Secondary Outcome Measures

Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.
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.
Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%
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.
Impact of the Novel Communication Intervention on parental hope.
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.
Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer.
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.
Impact of Novel Communication Intervention on parental satisfaction with healthcare
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: delivery of care; information received on child's diagnosis and treatments; inclusion of family; technical skills in managing their child's symptoms; and attention to their child's emotional needs.

Full Information

First Posted
February 19, 2020
Last Updated
October 1, 2023
Sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04330833
Brief Title
Informational Meetings for Planning and Coordinating Treatment
Acronym
IMPACT
Official Title
Informational Meetings for Planning and Coordinating Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life, Communication, Cancer Metastatic
Keywords
interventions, pediatric palliative care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.
Masking
ParticipantOutcomes Assessor
Masking Description
A trained blinded evaluator will meet with participants to complete baseline and subsequent follow-up measures, including end-of-study chart review data. Physician-nurse dyads for each arm are trained differently and naive to alternate study arm.
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care Parent Education
Arm Type
Active Comparator
Arm Description
Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.
Arm Title
Novel Communication Intervention
Arm Type
Experimental
Arm Description
Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.
Intervention Type
Other
Intervention Name(s)
Novel Communication Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care Parent Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
Description
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.
Time Frame
Within 12 months of death
Secondary Outcome Measure Information:
Title
Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.
Description
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.
Time Frame
Within 30 days of death
Title
Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%
Description
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.
Time Frame
Enrollment, then every 4 months until death or maximum of 4 years
Title
Impact of the Novel Communication Intervention on parental hope.
Description
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.
Time Frame
Enrollment, and then every 4 months until death or maximum of 4 years
Title
Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer.
Description
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.
Time Frame
Enrollment, and then every 4 months until death or maximum of 4 years
Title
Impact of Novel Communication Intervention on parental satisfaction with healthcare
Description
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: delivery of care; information received on child's diagnosis and treatments; inclusion of family; technical skills in managing their child's symptoms; and attention to their child's emotional needs.
Time Frame
Enrollment, and then every 4 months until death or maximum of 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan M Perkins, PhD
Phone
317-274-2626
Email
sperkin1@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Moody, MD
Phone
917-744-3130
Email
KMoody@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M Perkins, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Project Manager
Phone
720-777-6353
Facility Name
Nemours Children's Health
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Project Manager
Phone
302-651-6424
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Project Manager
Phone
317-274-4700
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Investigator
Phone
314-977-1906
Facility Name
MD Anderson Children's Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Program Manager
Phone
713-794-3637
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Project Manager
Phone
414-337-0276

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29513119
Citation
Hendricks-Ferguson VL, Ruebling I, Sargeant DM, Kienstra K, Eliot KA, Howell TG, Sebelski CA, Moore KS, Armstrong K. Undergraduate students' perspectives of healthcare professionals' use of shared decision-making skills. J Interprof Care. 2018 Jul;32(4):481-489. doi: 10.1080/13561820.2018.1443912. Epub 2018 Mar 7.
Results Reference
background
PubMed Identifier
27920233
Citation
Hendricks-Ferguson VL, Pradhan K, Shih CS, Gauvain KM, Kane JR, Liu J, Haase JE. Pilot Evaluation of a Palliative and End-of-Life Communication Intervention for Parents of Children With a Brain Tumor. J Pediatr Oncol Nurs. 2017 May/Jun;34(3):203-213. doi: 10.1177/1043454216676836.
Results Reference
background
PubMed Identifier
18980914
Citation
Hendricks-Ferguson V. Physical symptoms of children receiving pediatric hospice care at home during the last week of life. Oncol Nurs Forum. 2008 Nov;35(6):E108-15. doi: 10.1188/08.onf.e108-e115.
Results Reference
background
PubMed Identifier
22658379
Citation
Hendricks-Ferguson VL, Cherven BO, Burns DS, Docherty SL, Phillips-Salimi CR, Roll L, Stegenga KA, Donovan Stickler M, Haase JE. Recruitment strategies and rates of a multi-site behavioral intervention for adolescents and young adults with cancer. J Pediatr Health Care. 2013 Nov-Dec;27(6):434-42. doi: 10.1016/j.pedhc.2012.04.010. Epub 2012 Jun 2.
Results Reference
background
PubMed Identifier
22012943
Citation
Robb SL, Burns DS, Docherty SL, Haase JE. Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial. Psychooncology. 2011 Nov;20(11):1193-201. doi: 10.1002/pon.1845.
Results Reference
background
PubMed Identifier
27139113
Citation
Foster Akard T, Gerhardt CA, Hendricks-Ferguson V, Given B, Friedman DL, Hinds PS, Gilmer MJ. Facebook Advertising To Recruit Pediatric Populations. J Palliat Med. 2016 Jul;19(7):692-3. doi: 10.1089/jpm.2016.0128. Epub 2016 May 3. No abstract available.
Results Reference
background
PubMed Identifier
30939966
Citation
Sawin KJ, Montgomery KE, Dupree CY, Haase JE, Phillips CR, Hendricks-Ferguson VL. Oncology Nurse Managers' Perceptions of Palliative Care and End-of-Life Communication. J Pediatr Oncol Nurs. 2019 May/Jun;36(3):178-190. doi: 10.1177/1043454219835448. Epub 2019 Apr 3.
Results Reference
background
PubMed Identifier
25623029
Citation
Hendricks-Ferguson VL, Kane JR, Pradhan KR, Shih CS, Gauvain KM, Baker JN, Haase JE. Evaluation of Physician and Nurse Dyad Training Procedures to Deliver a Palliative and End-of-Life Communication Intervention to Parents of Children with a Brain Tumor. J Pediatr Oncol Nurs. 2015 Sep-Oct;32(5):337-47. doi: 10.1177/1043454214563410. Epub 2015 Jan 26.
Results Reference
background
PubMed Identifier
16635187
Citation
Horner S, Rew L, Torres R. Enhancing intervention fidelity: a means of strengthening study impact. J Spec Pediatr Nurs. 2006 Apr;11(2):80-9. doi: 10.1111/j.1744-6155.2006.00050.x.
Results Reference
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PubMed Identifier
27385664
Citation
Landier W, Ahern J, Barakat LP, Bhatia S, Bingen KM, Bondurant PG, Cohn SL, Dobrozsi SK, Haugen M, Herring RA, Hooke MC, Martin M, Murphy K, Newman AR, Rodgers CC, Ruccione KS, Sullivan J, Weiss M, Withycombe J, Yasui L, Hockenberry M. Patient/Family Education for Newly Diagnosed Pediatric Oncology Patients. J Pediatr Oncol Nurs. 2016 Nov/Dec;33(6):422-431. doi: 10.1177/1043454216655983. Epub 2016 Jul 9.
Results Reference
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PubMed Identifier
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Citation
Martin JS, Ummenhofer W, Manser T, Spirig R. Interprofessional collaboration among nurses and physicians: making a difference in patient outcome. Swiss Med Wkly. 2010 Sep 1;140:w13062. doi: 10.4414/smw.2010.13062. eCollection 2010.
Results Reference
background
PubMed Identifier
29620556
Citation
Hendricks-Ferguson VL, Haase JE. Parent Perspectives of Receiving Early Information About Palliative and End-of-Life Care Options From Their Child's Pediatric Providers. Cancer Nurs. 2019 Jul/Aug;42(4):E22-E30. doi: 10.1097/NCC.0000000000000589.
Results Reference
result
Links:
URL
https://www.cancer.gov/publications/patient-education/guide-for-parents
Description
National Cancer Institute Resource: Children with cancer: A parents' guide.

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Informational Meetings for Planning and Coordinating Treatment

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