Parent Educational Discharge Support Strategies

June 29, 2020 updated by: Duke University

Nurse-Led Parent Educational Discharge Support Strategies (PEDSS) for Children Newly Diagnosed With Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Providing education to parents of children newly diagnosed with cancer is a primary component of nursing practice, but best practices regarding delivery of information are not known. Parents often report confusion and worry with the complexity and large volume of information received during the initial hospitalization that leads to concerns in caring for their child after discharge. In addition, the amount and content of education is not standardized across institutions. This results in considerable variability in educational practices, including symptom education. During a recent qualitative study, parents described helpful discharge education strategies as having written materials, keeping information concise, and receiving anticipatory guidance so they knew what to expect. These preferences were succinctly summarized by a mother of a child newly diagnosed with leukemia who stated "…it would be nice to have one sheet of paper that just said 'these are the signs that you're looking for at home'." The purpose of this research study is to implement and evaluate parent educational discharge support strategies (PEDSS) for parents of children newly diagnosed with cancer. Findings from this study will provide a framework for nurses to deliver concise and consistent information to parents of children newly diagnosed with cancer, and will assist parents with their child after hospital discharge.

The goal of this study is to determine the effectiveness and feasibility of two parent education discharge support strategies (PEDSS - symptom management vs. PEDSS - support for the caregiver) for parents of children newly diagnosed with cancer. Specific aims of the study include:

Specific Aim 1: Explore the effects of parent education discharge support strategies on childhood cancer symptoms (fever, pain, fatigue, nausea, appetite changes, and sleep problems) and parents' perception of their ability to care for their child with a new cancer diagnosis during the first two months following the initial hospital discharge.

Specific Aim 2: Determine whether implementation of parent education discharge support strategies decreases unplanned utilization of healthcare services (unscheduled clinic visits, emergency room visits, unplanned hospitalizations), and preventable toxicity (malnutrition, sepsis) among children with cancer during the first two months following the initial hospitalization.

Specific Aim 3: Examine the feasibility and fidelity of implementing the PEDSS at the initial hospital discharge among parents of newly diagnosed children with cancer for use through the first two months following hospital discharge at participating Magnet institutions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
289

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12713 2796
        • King Faisal Specialist Hospital and Research Centre-Riyadh
  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann and Robert H. Lurie Children's Hospital of Chicago
      • Winfield, Illinois, United States, 60190
        • Northwestern Central DuPage Hospital
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Children's Cancer Program at Maine Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • St. Peter's University Hospital
    • New York
      • New Hyde Park, New York, United States, 11040
        • Cohen Children's Medical Center Northwell Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Levine Children's Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Children's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Health System of Texas Children's Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Health American Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PEDSS - symptom management
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
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.
Experimental: PEDSS - support for the caregiver
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline pain severity to two months
Time Frame: At baseline and monthly for two additional months
Wong-Baker Faces Scale
At baseline and monthly for two additional months
Change from baseline fatigue severity to two months
Time Frame: At baseline and monthly for two additional 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
Time Frame: At baseline and monthly for two additional 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
Time Frame: At baseline and monthly for two additional 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
Time Frame: At baseline and monthly for two additional months
The Sleep Wake Scale
At baseline and monthly for two additional months
Change from baseline pain behavior to two months
Time Frame: At baseline and monthly for two additional months
PROMIS® Pediatric - Pain Behavior Short Form
At baseline and monthly for two additional months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months
Time Frame: At baseline and monthly for two additional months
Seven items asking the parent to rate perceptions of the care of their child's symptoms on a 5-point Likert scale
At baseline and monthly for two additional months
Unplanned utilization of healthcare services
Time Frame: At one and two months from start of study
Combined frequency of the number of unscheduled clinic visits, emergency room visits, and unplanned hospitalizations
At one and two months from start of study
Change in baseline nutritional status to two months
Time Frame: At baseline and monthly for two additional months
Body mass index
At baseline and monthly for two additional months
Sepsis
Time Frame: At one and two months from start of study
Frequency of septic events over the past month
At one and two months from start of study
PEDSS intervention feasibility
Time Frame: At baseline
Nurse documentation of completion of PEDSS discussion and distribution of PEDSS worksheet
At baseline
PEDSS intervention satisfaction
Time Frame: At two months after intervention delivery
Descriptive items asking about timing of intervention and frequency of intervention use then 6 items scored on a 5-point Likert scale asking about ease of use and satisfaction.
At two months after intervention delivery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St. Jude Children's Research Hospital
Nationwide Children's Hospital
King Faisal Specialist Hospital & Research Center
St. Louis Children's Hospital
Levine Children's Hospital
Nicklaus Children's Hospital
Children's Health System of Texas Children's Medical Center
Cohen Children's Medical Center
Lurie Children's Hospital of Chicago
Maine Children's Cancer Program at Maine Medical Center
Medical University of South Carolina Children's Hospital
Northwestern Medicine Central DuPage Hospital
St. Peter's University Hospital
University of Wisconsin Health American Children's Hospital
West Virginia Univeristy Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marilyn Hockenberry, PhD, Duke University
  • Study Director: Megan Arthur, BS, Duke University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00077090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

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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