Clinical trial NCT03227068: Parent Educational Discharge Support Strategies
Official title: Nurse-Led Parent Educational Discharge Support Strategies (PEDSS) for Children Newly Diagnosed With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Activities
Keywords: pediatric oncology
parent
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Children's Health System of Texas Children's Medical Center
name: Cohen Children's Medical Center
name: Levine Children's Hospital
name: Lurie Children's Hospital of Chicago
name: Maine Children's Cancer Program at Maine Medical Center
name: Medical University of South Carolina Children's Hospital
name: Nationwide Children's Hospital
name: Northwestern Medicine Central DuPage Hospital
name: St. Jude Children's Research Hospital
name: St. Louis Children's Hospital
name: St. Peter's University Hospital
name: University of Wisconsin Health American Children's Hospital
name: West Virginia Univeristy Medicine
name: King Faisal Specialist Hospital & Research Center
name: Nicklaus Children's Hospital
First posted: 2017-07-24
Enrollment: 289
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects in both groups 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 including a list of home medications, and information regarding whom to call for emergencies. The PEDSS - symptom management and PEDSS - support for the caregiver are additional tools designed to reinforce care after the initial hospital discharge.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline pain severity to two months
timeFrame: At baseline and monthly for two additional months
measure: Change from baseline fatigue severity to two months
timeFrame: At baseline and monthly for two additional months
measure: Change from baseline nausea severity to two months
timeFrame: At baseline and monthly for two additional months
measure: Change from baseline appetite changes to two months
timeFrame: At baseline and monthly for two additional months
measure: Change from baseline sleep disturbances to two months
timeFrame: At baseline and monthly for two additional months
measure: Change from baseline pain behavior to two months
timeFrame: At baseline and monthly for two additional months
Secondary outcomes:
measure: Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months
timeFrame: At baseline and monthly for two additional months
measure: Unplanned utilization of healthcare services
timeFrame: At one and two months from start of study
measure: Change in baseline nutritional status to two months
timeFrame: At baseline and monthly for two additional months
measure: Sepsis
timeFrame: At one and two months from start of study
measure: PEDSS intervention feasibility
timeFrame: At baseline
measure: PEDSS intervention satisfaction
timeFrame: At two months after intervention delivery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Winfield
country: United States
facility: Northwestern Central DuPage Hospital
state: Illinois
city: Scarborough
country: United States
facility: Maine Children's Cancer Program at Maine Medical Center
state: Maine
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center Northwell Health
state: New York
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina Children's Hospital
state: South Carolina
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Dallas
country: United States
facility: Children's Health System of Texas Children's Medical Center
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Medicine
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Health American Children's Hospital
state: Wisconsin
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Centre-Riyadh
Study officials:
affiliation: Duke University
name: Marilyn Hockenberry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Megan Arthur, BS
role: STUDY_DIRECTOR
References: