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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:

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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.

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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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