NCT03227068

Brief Summary

After the initial hospitalization, parents of children newly diagnosed with cancer assume responsibility for assessing and managing their care; however, parents are often overwhelmed with information received throughout the hospitalization and are apprehensive about caring for their child at home. Parents want concise, focused information on how to care for their child after the hospital discharge. Two parent education discharge support strategies (PEDSS) were created to use at hospital discharge. PEDSS consists of a symptom management intervention and a support for the caregiver intervention. A cluster randomized control trial will assess the effectiveness and feasibility of the two different interventions.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 29, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

July 17, 2017

Last Update Submit

June 29, 2020

Conditions

Educational Activities

Keywords

pediatric oncologyparent

Outcome Measures

Primary Outcomes (6)

  • Change from baseline pain severity to two months

    Wong-Baker Faces Scale

    At baseline and monthly for two additional months

  • Change from baseline fatigue severity to two months

    Categorized as none to mild or moderate to severe from the Adolescent Fatigue Scale for adolescents 13-17 years of age, the Childhood Fatigue Scale for children 7-12 years of age, or the Parent Fatigue Scale to obtain proxy responses from parents of children \< 7 years of age

    At baseline and monthly for two additional months

  • Change from baseline nausea severity to two months

    Visual Analogue Scale in the form of a thermometer that rates the severity of nausea from 0-100

    At baseline and monthly for two additional months

  • Change from baseline appetite changes to two months

    Simplified Nutritional Appetite Questionnaire, 4-item asking about child's appetite and rated on a 5-point Likert Scale

    At baseline and monthly for two additional months

  • Change from baseline sleep disturbances to two months

    The Sleep Wake Scale

    At baseline and monthly for two additional months

  • Change from baseline pain behavior to two months

    PROMIS® Pediatric - Pain Behavior Short Form

    At baseline and monthly for two additional months

Secondary Outcomes (6)

  • Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months

    At baseline and monthly for two additional months

  • Unplanned utilization of healthcare services

    At one and two months from start of study

  • Change in baseline nutritional status to two months

    At baseline and monthly for two additional months

  • Sepsis

    At one and two months from start of study

  • PEDSS intervention feasibility

    At baseline

  • +1 more secondary outcomes

Study Arms (2)

PEDSS - symptom management

EXPERIMENTAL

Content for the PEDSS - symptom management includes the most commonly experienced treatment-related physical symptoms, descriptions of each symptom, strategies to reduce symptom distress, and when and how to contact the cancer care team.

Other: PEDSS - symptom management

PEDSS - support for the caregiver

EXPERIMENTAL

Content for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time.

Other: PEDSS - support for the caregiver

Interventions

PEDSS - symptom managementOTHER

All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - symptom management will be delivered prior to the initial hospital discharge. The nurse will review the symptom management worksheet verbally with the parent, then distribute the written worksheet to the parent.

PEDSS - symptom management
PEDSS - support for the caregiverOTHER

All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - support for the caregiver will be delivered prior to the initial hospital discharge. The nurse will review the worksheet verbally with the parent, then distribute the written worksheet to the parent.

PEDSS - support for the caregiver

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A parent (referred to as "parent" but includes a parent or legal guardian) of a patient 3 to 17 years of age who is newly diagnosed with any type of malignant disease on an inpatient oncology unit
  • Must speak English, Spanish, or Arabic
  • Child will be or is receiving chemotherapy and/or radiation therapy

You may not qualify if:

  • A parent of a child diagnosed with histiocytosis or any hematological disease considered non-malignant
  • A parent whose child received the initial cancer diagnosis and initial cancer treatment while hospitalized on a non-oncology unit (i.e., surgical ward)
  • A parent of a child who is experienced a relapse of a malignant disease
  • A parent who is the primary caregiver of the child with cancer and is illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Northwestern Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Maine Children's Cancer Program at Maine Medical Center

Scarborough, Maine, 04074, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

St. Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Cohen Children's Medical Center Northwell Health

New Hyde Park, New York, 11040, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, 29425, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Children's Health System of Texas Children's Medical Center

Dallas, Texas, 75235, United States

Location

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin Health American Children's Hospital

Madison, Wisconsin, 53792, United States

Location

King Faisal Specialist Hospital and Research Centre-Riyadh

Riyadh, 12713 2796, Saudi Arabia

Location

Study Officials

  • Marilyn Hockenberry, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Megan Arthur, BS

    Duke University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: All subjects in both groups will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge including a list of home medications, and information regarding whom to call for emergencies. The PEDSS - symptom management and PEDSS - support for the caregiver are additional tools designed to reinforce care after the initial hospital discharge.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 24, 2017

Study Start

December 29, 2017

Primary Completion

June 29, 2020

Study Completion

June 29, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Each site PI participating in the study will receive a copy of their anonymous data upon completion of the study.

Locations

US(15)SA(1)