Educational ActivitiesNCT03227068
Parent Educational Discharge Support Strategies
A study testing PEDSS - symptom management and PEDSS - support for the caregiver in people with Educational Activities, run by Duke University at 16 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Educational Activities
- What is being tested?
- PEDSS - symptom management and PEDSS - support for the caregiver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 29 Dec 2017to 29 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
Levine Children's Hospital
Charlotte, North Carolina, 28203
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Health System of Texas Children's Medical Center
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
University of Wisconsin Health American Children's Hospital
Madison, Wisconsin, 53792
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Nicklaus Children's Hospital
Miami, Florida, 33155
West Virginia University Medicine
Morgantown, West Virginia, 26506
St. Peter's University Hospital
New Brunswick, New Jersey, 08901
Cohen Children's Medical Center Northwell Health
New Hyde Park, New York, 11040
Maine Children's Cancer Program at Maine Medical Center
Scarborough, Maine, 04074
St. Louis Children's Hospital
St Louis, Missouri, 63110
Northwestern Central DuPage Hospital
Winfield, Illinois, 60190
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre-Riyadh
Riyadh, 12713 2796
About this study
Official title: Nurse-Led Parent Educational Discharge Support Strategies (PEDSS) for Children Newly Diagnosed With Cancer
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.
Read the 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.
- Conditions
- Educational Activities
- Being tested
- PEDSS - symptom management, PEDSS - support for the caregiver
- Keywords
- pediatric oncology, parent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDSS - symptom managementOther
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 caregiverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PEDSS - symptom management | Experimental | 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. Receives: Other: PEDSS - symptom management |
| PEDSS - support for the caregiver | Experimental | Content for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time. Receives: Other: PEDSS - support for the caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain severity to two months
Wong-Baker Faces Scale
Measured: At baseline and monthly for two additional months
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
Measured: At baseline and monthly for two additional months
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
Measured: At baseline and monthly for two additional months
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
Measured: At baseline and monthly for two additional months
Change from baseline sleep disturbances to two months
The Sleep Wake Scale
Measured: At baseline and monthly for two additional months
Change from baseline pain behavior to two months
PROMIS® Pediatric - Pain Behavior Short Form
Measured: At baseline and monthly for two additional months
Secondary outcomes (6)
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
Measured: At baseline and monthly for two additional months
Unplanned utilization of healthcare services
Combined frequency of the number of unscheduled clinic visits, emergency room visits, and unplanned hospitalizations
Measured: At one and two months from start of study
Change in baseline nutritional status to two months
Body mass index
Measured: At baseline and monthly for two additional months
Sepsis
Frequency of septic events over the past month
Measured: At one and two months from start of study
PEDSS intervention feasibility
Nurse documentation of completion of PEDSS discussion and distribution of PEDSS worksheet
Measured: At baseline
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.
Measured: At two months after intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start29 Dec 2017
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ActivitiesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health System of Texas Children's Medical Center, Cohen Children's Medical Center, Levine Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Maine Children's Cancer Program at Maine Medical Center, Medical University of South Carolina Shawn Jenkins Children's Hospital, Nationwide 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, King Faisal Specialist Hospital & Research Center, Nicklaus Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Marilyn Hockenberry, PhD, Principal investigator, Duke UniversityMegan Arthur, BS, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227068
- Sponsor's protocol ID
- Pro00077090
- Status last verified
- Jun 2020
- First submitted
- 17 Jul 2017
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each site PI participating in the study will receive a copy of their anonymous data upon completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Parent Educational Discharge Support Strategies (PEDSS) for Children Newly Diagnosed With Cancer
- ClinicalTrials.gov ID
- NCT03227068
- Acronym / sponsor ID
- Pro00077090
- Conditions
- Educational Activities
- Keywords
- pediatric oncology, parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Children's Health System of Texas Children's Medical Center, Cohen Children's Medical Center, Levine Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Maine Children's Cancer Program at Maine Medical Center, Medical University of South Carolina Shawn Jenkins Children's Hospital, Nationwide 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, King Faisal Specialist Hospital & Research Center, Nicklaus Children's Hospital
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PEDSS - symptom management | Experimental | Other: PEDSS - symptom managementContent 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 - support for the caregiver | Experimental | Other: PEDSS - support for the caregiverContent for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEDSS - symptom managementAll 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. | Other | PEDSS - symptom management |
| PEDSS - support for the caregiverAll 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. | Other | PEDSS - support for the caregiver |
Primary outcome
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 sleep disturbances to two months
Time frame: At baseline and monthly for two additional months
The Sleep Wake 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
6 secondary outcomes
Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months
Time frame: At baseline and monthly for two additional months
Unplanned utilization of healthcare services
Time frame: At one and two months from start of study
Change in baseline nutritional status to two months
Time frame: At baseline and monthly for two additional months
Sepsis
Time frame: At one and two months from start of study
PEDSS intervention feasibility
Time frame: At baseline
PEDSS intervention satisfaction
Time frame: At two months after intervention delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No. Each site PI participating in the study will receive a copy of their anonymous data upon completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Hockenberry, PhD principal investigator
Duke University
Megan Arthur, BS study director
Duke University
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEDSS - symptom management and PEDSS - support for the caregiver in people with Educational Activities, run by Duke University at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain severity to two months (time frame: At baseline and monthly for two additional months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.