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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03227068
Other study ID # Pro00077090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 29, 2017
Est. completion date June 29, 2020

Study information

Verified date June 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date June 29, 2020
Est. primary completion date June 29, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Saudi Arabia King Faisal Specialist Hospital and Research Centre-Riyadh Riyadh
United States Medical University of South Carolina Children's Hospital Charleston South Carolina
United States Levine Children's Hospital Charlotte North Carolina
United States Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Nationwide Children's Hospital Columbus Ohio
United States Children's Health System of Texas Children's Medical Center Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States University of Wisconsin Health American Children's Hospital Madison Wisconsin
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Nicklaus Children's Hospital Miami Florida
United States West Virginia University Medicine Morgantown West Virginia
United States St. Peter's University Hospital New Brunswick New Jersey
United States Cohen Children's Medical Center Northwell Health New Hyde Park New York
United States St. Louis Children's Hospital Saint Louis Missouri
United States Maine Children's Cancer Program at Maine Medical Center Scarborough Maine
United States Northwestern Central DuPage Hospital Winfield Illinois

Sponsors (16)

Lead Sponsor Collaborator
Duke University Children's Health System of Texas Children's Medical Center, Cohen Children's Medical Center, King Faisal Specialist Hospital & Research Center, Levine Children's Hospital, Lurie Children's Hospital of Chicago, Maine Children's Cancer Program at Maine Medical Center, Medical University of South Carolina Children's Hospital, Nationwide Children's Hospital, Nicklaus Children's Hospital, Northwestern Medicine Central DuPage Hospital, St. Jude Children's Research Hospital, St. Louis Children's Hospital, St. Peter's University Hospital, University of Wisconsin Health American Children's Hospital, West Virginia Univeristy Medicine

Countries where clinical trial is conducted

United States,  Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline pain severity to two months Wong-Baker Faces Scale At baseline and monthly for two additional months
Primary 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
Primary 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
Primary 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
Primary Change from baseline sleep disturbances to two months The Sleep Wake Scale At baseline and monthly for two additional months
Primary Change from baseline pain behavior to two months PROMIS® Pediatric - Pain Behavior Short Form At baseline and monthly for two additional months
Secondary Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two 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
Secondary Unplanned utilization of healthcare services Combined frequency of the number of unscheduled clinic visits, emergency room visits, and unplanned hospitalizations At one and two months from start of study
Secondary Change in baseline nutritional status to two months Body mass index At baseline and monthly for two additional months
Secondary Sepsis Frequency of septic events over the past month At one and two months from start of study
Secondary PEDSS intervention feasibility Nurse documentation of completion of PEDSS discussion and distribution of PEDSS worksheet At baseline
Secondary PEDSS intervention satisfaction 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
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