Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
289 participants
INTERVENTIONAL
2017-12-29
2020-06-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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
Content for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Must speak English, Spanish, or Arabic
* Child will be or is receiving chemotherapy and/or radiation therapy
Exclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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Children's Health System of Texas Children's Medical Center
UNKNOWN
Cohen Children's Medical Center
OTHER
Levine Children's Hospital
OTHER
Lurie Children's Hospital of Chicago
UNKNOWN
Maine Children's Cancer Program at Maine Medical Center
UNKNOWN
Medical University of South Carolina Children's Hospital
UNKNOWN
Nationwide Children's Hospital
OTHER
Northwestern Medicine Central DuPage Hospital
UNKNOWN
St. Jude Children's Research Hospital
OTHER
St. Louis Children's Hospital
OTHER
St. Peter's University Hospital
UNKNOWN
University of Wisconsin Health American Children's Hospital
UNKNOWN
West Virginia Univeristy Medicine
UNKNOWN
King Faisal Specialist Hospital & Research Center
OTHER
Nicklaus Children's Hospital
UNKNOWN
Duke University
OTHER
Responsible Party
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Principal Investigators
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Marilyn Hockenberry, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Megan Arthur, BS
Role: STUDY_DIRECTOR
Duke University
Locations
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Nicklaus Children's Hospital
Miami, Florida, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern Central DuPage Hospital
Winfield, Illinois, United States
Maine Children's Cancer Program at Maine Medical Center
Scarborough, Maine, United States
St. Louis Children's Hospital
St Louis, Missouri, 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
Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Children's Health System of Texas Children's Medical Center
Dallas, Texas, United States
West Virginia University Medicine
Morgantown, West Virginia, United States
University of Wisconsin Health American Children's Hospital
Madison, Wisconsin, United States
King Faisal Specialist Hospital and Research Centre-Riyadh
Riyadh, , Saudi Arabia
Countries
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Other Identifiers
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Pro00077090
Identifier Type: -
Identifier Source: org_study_id
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