LeukemiaNCT04813783
The Effect of Mucositis Care Training Given to Caregivers in Pediatric Leukemia Cases on Mucosal Barrier Damage
An observational study of Leukemia and Mucositis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
There are studies in the literature that include parent training for the prevention and care of mucositis. Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Leukemia, Mucositis, Nursing Care
- What is being tested?
- Mucositis care training to be given in line with MASCC / ISOO 2019
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population of the study will be the cases in the 2-18 age group followed in the Ege University Faculty of Medicine Children's Hospital Pediatric Hematology Clinic and their primary caregiver parents.
Who may be able to join
- The case is between the ages of 2-18
- The patient is followed up in the Pediatric Hematology Clinic
- The patient is only receiving leukaemia treatment
- The patient is receiving chemotherapy suitable for the high-risk group (T-ALL, High Risk ALL [Protocol HR1-2-3], Middle Risk ALL [Protocol M, Mtx 5gr / m2] The patient does not have any other chronic disease
- The patient does not have a systemic infection
- The patient has a central venous catheter or port catheter Volunteering of the mother and the caregiver parent
- The caring parent knows Turkish and is open to communication
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
There are studies in the literature that include parent training for the prevention and care of mucositis.
Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations.
Read more
The regulations focus on the educative role of the nurse for patients. In pediatric oncology clinics where leukaemia treatment and care is provided, the educational role of the nurse is directed towards the child individual and their family, and determining and meeting the educational needs of the whole family is vital in the nursing management of the child with cancer.
In this context, this study aims to examine the effect of mucositis care training to caregivers of pediatric patients aged 2 to 18 years, on the development of mucositis and the clinic's "mucosal barrier damage, laboratory-confirmed bloodstream infections".
Read the detailed description
Children who are treated for leukaemia are exposed to a wide variety of chemotherapeutic agents and immunosuppressive treatments during the treatment, therefore they are at high risk of complications. Gastrointestinal mucositis is the leading factor affecting the quality of life of the child among the chemotherapy-related complications.
Gastrointestinal mucositis (GM) can be defined as inflammation or ulceration in the gastrointestinal organs due to chemotherapy treatment. Symptoms of GM include abdominal pain, diarrhoea, bleeding, fatigue, malnutrition, dehydration, electrolyte imbalance, and secondary infections. GM can present in two forms as oral and anal mucositis. Both oral and anal all GMs have negative effects on growth and development in children. One of the main issues of the remedial approach in this regard is the provision of qualified mucositis care. There are studies in the literature that include parent training for the prevention and care of mucositis.
Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations. The regulations focus on the educative role of the nurse for patients. In pediatric oncology clinics where leukaemia treatment and care is provided, the educational role of the nurse is directed towards the child individual and their family, and determining and meeting the educational needs of the whole family is vital in the nursing management of the child with cancer.
In this context, this study aims to examine the effect of mucositis care training to caregivers of pediatric patients aged 2 to 18 years, on the development of mucositis and the clinic's "mucosal barrier damage, laboratory-confirmed bloodstream infections".
- Conditions
- Leukemia, Mucositis, Nursing Care, Pediatric ALL
- Being tested
- Mucositis care training to be given in line with MASCC / ISOO 2019
- Medical subject headings
- Leukemia, Mucositis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucositis care training to be given in line with MASCC / ISOO 2019Other
Mucositis care training to be given in line with MASCC / ISOO 2019
| Study group | Role | What they receive |
|---|---|---|
| Control group | The first group of 26 volunteers who meet the inclusion criteria of the study will form the control group. These participants will be given clinical routine training about mucositis care. | |
| Intervention Group | In the study, in order to prevent/minimize the flow of information between the control and intervention groups, the data of the control group will be collected first. Data collection will be suspended in the clinic for three months after the control group data is completed. After this period, data of the enterprise group will be collected. Participants in the intervention group will be provided with mucositis training within the scope of the Mucositis Care Protocol in line with the MASCC / ISOO 2019 Recommendations. Receives: Other: Mucositis care training to be given in line with MASCC / ISOO 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mucositis knowledge scores of caregivers
It is the form prepared by the researchers in line with the literature, questioning the parents' knowledge of the definition of oral/anal mucositis and the application of care principles in mucositis.
Measured: change from baseline to three days after training
change of weight
change in the child's body weight
Measured: change from baseline to seven days after training
change of the degree of mucositis
the change in the child's mucositis by using WHO Mucositis Scale
Measured: through study completion, an average of 2 weeks
change of pain level due to mucositis with WB Scale
It is the form that includes the pain assessment scale suitable for the child's age. The Wong-Baker Facial Pain Scale will be used for children aged 2 months to 6 years
Measured: through study completion, an average of 2 weeks
change of pain level due to mucositis with Numeric Pain Scale
It is the form that includes the pain assessment scale suitable for the child's age. The Numerical Pain Scale for children aged 7 and above.
Measured: through study completion, an average of 2 weeks
Change of Pediatric Oral / Anal Mucositis Care Skills
It is a form prepared by researchers in line with the literature in which the skills of parents regarding the application of care principles in oral / anal mucositis are questioned.
Measured: change from baseline to three days after training
Change of Mucosal barrier injury laboratory-confirmed bloodstream infection rate
It is a test to eveluate mucosal barrier injury laboratory-confirmed bloodstream infection rate
Measured: change from baseline to seven days after training
oral mucositis area measurement
The measurement will be evaluated with IMITO Wound Application
Measured: change from baseline to seven days after 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 May 2021
- Primary completion1 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Ege 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ARDAHAN SEVGİLİ, Ege University
- Investigators
- SELMİN ŞENOL, Study chair, KÜTAHYA UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813783
- Sponsor's protocol ID
- 20-6.1T/62
- Status last verified
- Feb 2023
- First submitted
- 20 Mar 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mucositis Care Training Given to Caregivers in Pediatric Leukemia Cases on Mucosal Barrier Damage
- ClinicalTrials.gov ID
- NCT04813783
- Acronym / sponsor ID
- 20-6.1T/62
- Conditions
- Leukemia, Mucositis, Nursing Care, Pediatric ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Mar 2021 (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.
There are studies in the literature that include parent training for the prevention and care of mucositis.
Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations.
The regulations focus on the educative role of the nurse for patients. In pediatric oncology clinics where leukaemia treatment and care is provided, the educational role of the nurse is directed towards the child individual and their family, and determining and meeting the educational needs of the whole family is vital in the nursing management of the child with cancer.
In this context, this study aims to examine the effect of mucositis care training to caregivers of pediatric patients aged 2 to 18 years, on the development of mucositis and the clinic's "mucosal barrier damage, laboratory-confirmed bloodstream infections".
Detailed description
Children who are treated for leukaemia are exposed to a wide variety of chemotherapeutic agents and immunosuppressive treatments during the treatment, therefore they are at high risk of complications. Gastrointestinal mucositis is the leading factor affecting the quality of life of the child among the chemotherapy-related complications.
Gastrointestinal mucositis (GM) can be defined as inflammation or ulceration in the gastrointestinal organs due to chemotherapy treatment. Symptoms of GM include abdominal pain, diarrhoea, bleeding, fatigue, malnutrition, dehydration, electrolyte imbalance, and secondary infections. GM can present in two forms as oral and anal mucositis. Both oral and anal all GMs have negative effects on growth and development in children. One of the main issues of the remedial approach in this regard is the provision of qualified mucositis care. There are studies in the literature that include parent training for the prevention and care of mucositis.
Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations. The regulations focus on the educative role of the nurse for patients. In pediatric oncology clinics where leukaemia treatment and care is provided, the educational role of the nurse is directed towards the child individual and their family, and determining and meeting the educational needs of the whole family is vital in the nursing management of the child with cancer.
In this context, this study aims to examine the effect of mucositis care training to caregivers of pediatric patients aged 2 to 18 years, on the development of mucositis and the clinic's "mucosal barrier damage, laboratory-confirmed bloodstream infections".
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –The first group of 26 volunteers who meet the inclusion criteria of the study will form the control group. These participants will be given clinical routine training about mucositis care. |
| Intervention Group | – | Other: Mucositis care training to be given in line with MASCC / ISOO 2019In the study, in order to prevent/minimize the flow of information between the control and intervention groups, the data of the control group will be collected first. Data collection will be suspended in the clinic for three months after the control group data is completed. After this period, data of the enterprise group will be collected. Participants in the intervention group will be provided with mucositis training within the scope of the Mucositis Care Protocol in line with the MASCC / ISOO 2019 Recommendations. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population of the study will be the cases in the 2-18 age group followed in the Ege University Faculty of Medicine Children's Hospital Pediatric Hematology Clinic and their primary caregiver parents.
Key inclusion criteria (7 listed)
- The case is between the ages of 2-18
- The patient is followed up in the Pediatric Hematology Clinic
- The patient is only receiving leukaemia treatment
- The patient is receiving chemotherapy suitable for the high-risk group (T-ALL, High Risk ALL [Protocol HR1-2-3], Middle Risk ALL [Protocol M, Mtx 5gr / m2] The patient does not have any other chronic disease
- The patient does not have a systemic infection
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Mucositis care training to be given in line with MASCC / ISOO 2019Mucositis care training to be given in line with MASCC / ISOO 2019 | Other | Intervention Group |
Primary outcome
Change of Mucositis knowledge scores of caregivers
Time frame: change from baseline to three days after training
It is the form prepared by the researchers in line with the literature, questioning the parents' knowledge of the definition of oral/anal mucositis and the application of care principles in mucositis.
change of weight
Time frame: change from baseline to seven days after training
change in the child's body weight
change of the degree of mucositis
Time frame: through study completion, an average of 2 weeks
the change in the child's mucositis by using WHO Mucositis Scale
change of pain level due to mucositis with WB Scale
Time frame: through study completion, an average of 2 weeks
It is the form that includes the pain assessment scale suitable for the child's age. The Wong-Baker Facial Pain Scale will be used for children aged 2 months to 6 years
change of pain level due to mucositis with Numeric Pain Scale
Time frame: through study completion, an average of 2 weeks
It is the form that includes the pain assessment scale suitable for the child's age. The Numerical Pain Scale for children aged 7 and above.
Change of Pediatric Oral / Anal Mucositis Care Skills
Time frame: change from baseline to three days after training
It is a form prepared by researchers in line with the literature in which the skills of parents regarding the application of care principles in oral / anal mucositis are questioned.
Change of Mucosal barrier injury laboratory-confirmed bloodstream infection rate
Time frame: change from baseline to seven days after training
It is a test to eveluate mucosal barrier injury laboratory-confirmed bloodstream infection rate
oral mucositis area measurement
Time frame: change from baseline to seven days after 21 days
The measurement will be evaluated with IMITO Wound Application
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 10 Feb 2023.
- Individual participant dataSharing planned: No
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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.
SELMİN ŞENOL study chair
KÜTAHYA UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Mucositis, run by Ege University at 1 site in Turkey (Türkiye).
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 7 inclusion and 1 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 of Mucositis knowledge scores of caregivers (time frame: change from baseline to three days after training). The study lists 8 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 10 Feb 2023.