Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05982379
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2023-07-25
Brief Title:
Motivation Program for Children With Cancer
Sponsor:
Zeynep Kisecik Şengül
Organization:
Kırıkkale University
Study Overview
Official Title:
Investigation Into the Impact of Technology-Based Motivation Program Applied to the Children Followed With Cancer Diagnosis and Their Families A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose To determine the effectiveness of the technology-based motivation program implemented with children with cancer diagnosis and their primary caregivers
Methods This randomized controlled trial was completed with 31 children and 31 primary caregivers between the ages of 9 and18 who were being treated for cancer A 10-week Technology Based Motivation Program was given to the intervention group State Trait Anxiety Inventory for Children Paediatric Quality of Life Inventory Paediatric Cancer Coping Scale State and Trait Anxiety Inventory and Process Evaluation Forms were administered Chi-square test Fisher-Exact test Independent Sample-t test Man-Whitney U test Wilcoxon test Pearson and Spearman correlation coefficients were used for data analysis
Methods This randomized controlled trial was completed with 31 children and 31 primary caregivers between the ages of 9 and18 who were being treated for cancer A 10-week Technology Based Motivation Program was given to the intervention group State Trait Anxiety Inventory for Children Paediatric Quality of Life Inventory Paediatric Cancer Coping Scale State and Trait Anxiety Inventory and Process Evaluation Forms were administered Chi-square test Fisher-Exact test Independent Sample-t test Man-Whitney U test Wilcoxon test Pearson and Spearman correlation coefficients were used for data analysis
Detailed Description:
Design The study was conducted in two hospitals at Leukemia Polyclinic Paediatric Haematology and Oncology Polyclinic and Paediatric Haematology-Oncology Service from September 2019 to August 2020
Setting and Samples In determining the research population hospital registry information was used and 119 children followed up with a diagnosis of cancer formed the research population The sample of the research consisted of 44 children leukaemia n 33 solid tumour n 11 and their primary caregivers meeting the inclusion criteria
Randomization and blinding A stratified randomization method was used in the research 44 children leukaemia and solid tumour who met the inclusion criteria were grouped according to gender male and female and age 9-13 years-14-18 years and eight layers were obtained Among the identified strata intervention and control groups were randomized by an independent statistician using the website wwwrandomizerorg 22 children were assigned to the intervention and 22 to the control group Five children from the intervention group and five children from the control group unreachable n3 ex n1 refusal n4 Hematopoietic stem cell transplantation HSCT performed n1 intensive care unit admission n1 could not be included in the research for various reasons and 34 children were included in the research The purpose and content of the research were explained without informing the children and their primary caregivers that they were in the intervention or control group
At the end of the research the power analysis performed by using the mean scores of State Anxiety Inventory for Children with G Power 3010 program yielded a total of at least 28 samples that were found to be sufficient with 90 power and 5 margin of error n1 14 n2 14
Theoretical underpinnings The use of models is important in establishing the theoretical framework of research In this research the Transactional Stress and Coping Model of Lazarus and Folkman which is the most widely used model in studies examining the coping and anxiety levels of children with cancer diagnosis was used The practices in the motivation program were created for the coping strategies of seeking social support self-control positive evaluation and accepting responsibility in the model
Interventions The research consists of four stages 1 Constructing training modules 2 Creating a website 3 Conducting preliminary intervention and 4 Implementing the training modules with the children and primary caregivers in the intervention group
Constructing training modules Four training modules for children and three training modules for primary caregivers were created by the researchers in line with the literature Content was added to the website after it was approved by 6 experts
Creating the website The website was designed by a professional web design firm The website can be accessed by computer tablet and phone There is an administrator and user panel on the website Children and primary caregivers logged on the website with different passwords through the user panel and accessed the modules specially prepared for them
Conducting preliminary intervention The preliminary intervention of the technology-based program was conducted with five children aged 9-18 years who were followed up with a diagnosis of leukaemia and with their primary caregivers As the child and primary caregivers found the program applicable as a result of the preliminary intervention no change was made and it was included in the sample
Using the training modules with children and primary caregivers in the intervention group The website and four training modules were used with the children in the intervention group Nine coaching interviews with each child once a week were conducted over WhatsApp The children were encouraged to do progressive relaxation and breathing exercises at least twice a week and eight therapeutic stories once a week were sent to the childs phone in the form of animation
Three training modules were used with the primary caregivers and coaching interviews were conducted on WhatsApp twice during the program Primary caregivers practiced progressive relaxation and breathing exercises at least twice a week In addition eight motivation messages were sent to the child and primary caregiver and 247 consultancy was provided
Control Group The routine practices of the children in the control group and their primary caregivers at the hospital continued In addition forms other than process evaluation were given to the child and their primary caregivers at the beginning and end of the program
Data gathering After the children and primary caregivers who participated in the research were informed about the research in an empty room or in the room where they were treated during the polyclinic controls data collection forms were given the children and primary caregivers in the intervention group were subscribed to the website and the exercises were explained in practice It took approximately 60 minutes for the participants to fill out the forms and learn about the program At the end of the research the data collection forms excluding the descriptive data form were collected through WhatsApp messages
Data collection tools Child and Parent Descriptive Characteristics Form Spielberger State-Trait Anxiety Inventory State Trait Anxiety Inventory for Children Paediatric Cancer Coping Scale Paediatric Quality of Life Inventory and Process Evaluation Forms were used to collect the data
Ethical considerations Permission for the research was obtained from the University Ethics Committee and Hospitals Informed written consent was obtained from the children and their primary caregivers who agreed to participate in the research after written and verbal explanations were given to the patients to participate in the research At the end of the study all interventions were also performed with the control group
Setting and Samples In determining the research population hospital registry information was used and 119 children followed up with a diagnosis of cancer formed the research population The sample of the research consisted of 44 children leukaemia n 33 solid tumour n 11 and their primary caregivers meeting the inclusion criteria
Randomization and blinding A stratified randomization method was used in the research 44 children leukaemia and solid tumour who met the inclusion criteria were grouped according to gender male and female and age 9-13 years-14-18 years and eight layers were obtained Among the identified strata intervention and control groups were randomized by an independent statistician using the website wwwrandomizerorg 22 children were assigned to the intervention and 22 to the control group Five children from the intervention group and five children from the control group unreachable n3 ex n1 refusal n4 Hematopoietic stem cell transplantation HSCT performed n1 intensive care unit admission n1 could not be included in the research for various reasons and 34 children were included in the research The purpose and content of the research were explained without informing the children and their primary caregivers that they were in the intervention or control group
At the end of the research the power analysis performed by using the mean scores of State Anxiety Inventory for Children with G Power 3010 program yielded a total of at least 28 samples that were found to be sufficient with 90 power and 5 margin of error n1 14 n2 14
Theoretical underpinnings The use of models is important in establishing the theoretical framework of research In this research the Transactional Stress and Coping Model of Lazarus and Folkman which is the most widely used model in studies examining the coping and anxiety levels of children with cancer diagnosis was used The practices in the motivation program were created for the coping strategies of seeking social support self-control positive evaluation and accepting responsibility in the model
Interventions The research consists of four stages 1 Constructing training modules 2 Creating a website 3 Conducting preliminary intervention and 4 Implementing the training modules with the children and primary caregivers in the intervention group
Constructing training modules Four training modules for children and three training modules for primary caregivers were created by the researchers in line with the literature Content was added to the website after it was approved by 6 experts
Creating the website The website was designed by a professional web design firm The website can be accessed by computer tablet and phone There is an administrator and user panel on the website Children and primary caregivers logged on the website with different passwords through the user panel and accessed the modules specially prepared for them
Conducting preliminary intervention The preliminary intervention of the technology-based program was conducted with five children aged 9-18 years who were followed up with a diagnosis of leukaemia and with their primary caregivers As the child and primary caregivers found the program applicable as a result of the preliminary intervention no change was made and it was included in the sample
Using the training modules with children and primary caregivers in the intervention group The website and four training modules were used with the children in the intervention group Nine coaching interviews with each child once a week were conducted over WhatsApp The children were encouraged to do progressive relaxation and breathing exercises at least twice a week and eight therapeutic stories once a week were sent to the childs phone in the form of animation
Three training modules were used with the primary caregivers and coaching interviews were conducted on WhatsApp twice during the program Primary caregivers practiced progressive relaxation and breathing exercises at least twice a week In addition eight motivation messages were sent to the child and primary caregiver and 247 consultancy was provided
Control Group The routine practices of the children in the control group and their primary caregivers at the hospital continued In addition forms other than process evaluation were given to the child and their primary caregivers at the beginning and end of the program
Data gathering After the children and primary caregivers who participated in the research were informed about the research in an empty room or in the room where they were treated during the polyclinic controls data collection forms were given the children and primary caregivers in the intervention group were subscribed to the website and the exercises were explained in practice It took approximately 60 minutes for the participants to fill out the forms and learn about the program At the end of the research the data collection forms excluding the descriptive data form were collected through WhatsApp messages
Data collection tools Child and Parent Descriptive Characteristics Form Spielberger State-Trait Anxiety Inventory State Trait Anxiety Inventory for Children Paediatric Cancer Coping Scale Paediatric Quality of Life Inventory and Process Evaluation Forms were used to collect the data
Ethical considerations Permission for the research was obtained from the University Ethics Committee and Hospitals Informed written consent was obtained from the children and their primary caregivers who agreed to participate in the research after written and verbal explanations were given to the patients to participate in the research At the end of the study all interventions were also performed with the control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None