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Clinical Trials/NCT03227068
NCT03227068
Completed
Not Applicable

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

Duke University16 sites in 2 countries289 target enrollmentDecember 29, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Educational Activities
Sponsor
Duke University
Enrollment
289
Locations
16
Primary Endpoint
Change from baseline pain severity to two months
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 29, 2017
End Date
June 29, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline pain severity to two months

Time Frame: At baseline and monthly for two additional months

Wong-Baker Faces Scale

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

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

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

Change from baseline pain behavior to two months

Time Frame: At baseline and monthly for two additional months

PROMIS® Pediatric - Pain Behavior Short Form

Change from baseline sleep disturbances to two months

Time Frame: At baseline and monthly for two additional months

The Sleep Wake Scale

Secondary Outcomes

  • 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)
  • 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)
  • Sepsis(At one and two months from start of study)
  • PEDSS intervention feasibility(At baseline)
  • PEDSS intervention satisfaction(At two months after intervention delivery)

Study Sites (16)

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