Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-05 @ 3:47 AM
Study NCT ID:
NCT06389357
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2024-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retun-to-school Adaptation Program for Children With Cancer
Sponsor:
Gazi University
Organization:
Study Overview
Official Title:
Efficacy of the Web-based Return-to-school Adaptation Program for Children Diagnosed With Cancer
Status:
COMPLETED
Status Verified Date:
2025-08
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:
web-based
Brief Summary:
The aim of this action research is to:
Stage 1: Conduct an in-depth investigation into the adaptation challenges faced by children aged 8-17 who are being treated for cancer during their return to school, from both the children's and parents' perspectives;
Stage 2: Develop a structured, evidence-based, and digitally accessible intervention program that addresses these identified needs;
Stage 3: Evaluate the feasibility and effectiveness of the intervention; and
Ultimately, based on all data gathered throughout the implementation process, continuously refine the intervention and analyze participant feedback holistically in order to establish a sustainable support model.
Stage 1: Conduct an in-depth investigation into the adaptation challenges faced by children aged 8-17 who are being treated for cancer during their return to school, from both the children's and parents' perspectives;
Stage 2: Develop a structured, evidence-based, and digitally accessible intervention program that addresses these identified needs;
Stage 3: Evaluate the feasibility and effectiveness of the intervention; and
Ultimately, based on all data gathered throughout the implementation process, continuously refine the intervention and analyze participant feedback holistically in order to establish a sustainable support model.
Detailed Description:
Importance of research There are disease-specific medical and psychosocial difficulties that children with a diagnosis of cancer may experience. Standard school nursing practices can be helpful in meeting the physical, emotional, psychological, social and academic needs of children. However, a standard of care that is decided to be applied on return to school has not been developed. Therefore, it is thought that standard school nursing practices are not sufficient to meet the health and educational needs of children with cancer diagnosis. In the world, plans have been made using practices/methods/models appropriate for the population in the school return process of children followed up with a diagnosis of cancer. It is recommended to develop back-to-school programmes as they can benefit the child, family, peers, teachers and school staff who are followed up with a diagnosis of cancer. In our study, we aim to manage the transition care schematically with the back-to-school protocol to be made between the school-family-hospital, and to ensure care coordination and the safety of the child. The fact that the intervention in the back-to-school adaptation programme will be made to the child, parents, teachers and peers shows a holistic approach to the needs.
Place of application:
It will be performed in the paediatric leukaemia outpatient clinic of the Children's Hospital.
Study Population The population of the study consisted of children who were followed up in the paediatric leukaemia outpatient clinic of the Children's Hospital with a diagnosis of cancer.
Sample of the study In Phase 1, it was observed that after a certain number of interviews, no new themes or concepts emerged, and the data began to repeat previously obtained information. Accordingly, it was concluded that data saturation had been reached, and the data collection process was terminated. The sample for Phase 1 consisted of 12 children and their parents (n = 12).
In Phase 3, the study was conducted using a pre-experimental research design with a single group consisting only of the intervention group during the school re-entry adaptation program.
In program evaluation studies, a medium effect size is generally considered sufficient for quantitative evaluation methods. Accordingly, an effect size (Cohen's f) of at least 0.25 is recommended (Crisan \& Elliott, 2018). For sample size planning, our study determined the estimated sample size to be 24 participants, based on 80% power and a 5% margin of error. The program in phase-3 was completed with 20 children and their parents who agreed to participate in the program.
Data Collection Tools
Phase 1: Identifying the experiences of children diagnosed with cancer and their parents during the return-to-school process - Descriptive phenomenological study:
The Child and Parent Descriptive Information Form Semi-Structured Interview Form
Phase 3: Implementation and evaluation of the school re-entry adaptation program:
1. Child and Parent Descriptive Information Form
2. Data Collection Form for Children's Return to School Process
3. Social Anxiety Scale for Children-Revised Version
4. Social Anxiety Scale for Adolescents
5. Paediatric Cancer Coping Scale
6. Readiness to Return to School Scale for Children with Oncological Problems: 7-18 Age
7. Process Evaluation Forms
Statistical analysis
Phase 1 - Qualitative Study:
The audio recordings of the interviews were transcribed. The qualitative data were analyzed using thematic content analysis via MAXQDA 2024 software. The steps of thematic analysis-transcription of the data, creation of codes, identification of themes, and reporting-were systematically followed to develop the context, main themes, and sub-themes. Codes were identified and grouped, which informed the final sub-theme and theme structure.
Sociodemographic characteristics collected during the qualitative phase were analyzed using SPSS version 30.0.0.0 and reported using frequencies and percentages.
Phase 3 - Implementation and Evaluation of the Program:
To assess the adaptation program, the normality of children's scale scores was evaluated using Shapiro-Wilk tests and skewness-kurtosis values. For variables that did not show a normal distribution, median values were reported (see Table 3.14).
The statistical significance of changes in scale scores over time within the sample group was examined using the Friedman test. A significance level of p ≤ 0.05 was accepted for all statistical tests. In cases where a statistically significant difference was found, Bonferroni-adjusted Wilcoxon Signed-Rank Tests were conducted to determine between which measurements the differences occurred, with a significance threshold set at p ≤ 0.01.
Place of application:
It will be performed in the paediatric leukaemia outpatient clinic of the Children's Hospital.
Study Population The population of the study consisted of children who were followed up in the paediatric leukaemia outpatient clinic of the Children's Hospital with a diagnosis of cancer.
Sample of the study In Phase 1, it was observed that after a certain number of interviews, no new themes or concepts emerged, and the data began to repeat previously obtained information. Accordingly, it was concluded that data saturation had been reached, and the data collection process was terminated. The sample for Phase 1 consisted of 12 children and their parents (n = 12).
In Phase 3, the study was conducted using a pre-experimental research design with a single group consisting only of the intervention group during the school re-entry adaptation program.
In program evaluation studies, a medium effect size is generally considered sufficient for quantitative evaluation methods. Accordingly, an effect size (Cohen's f) of at least 0.25 is recommended (Crisan \& Elliott, 2018). For sample size planning, our study determined the estimated sample size to be 24 participants, based on 80% power and a 5% margin of error. The program in phase-3 was completed with 20 children and their parents who agreed to participate in the program.
Data Collection Tools
Phase 1: Identifying the experiences of children diagnosed with cancer and their parents during the return-to-school process - Descriptive phenomenological study:
The Child and Parent Descriptive Information Form Semi-Structured Interview Form
Phase 3: Implementation and evaluation of the school re-entry adaptation program:
1. Child and Parent Descriptive Information Form
2. Data Collection Form for Children's Return to School Process
3. Social Anxiety Scale for Children-Revised Version
4. Social Anxiety Scale for Adolescents
5. Paediatric Cancer Coping Scale
6. Readiness to Return to School Scale for Children with Oncological Problems: 7-18 Age
7. Process Evaluation Forms
Statistical analysis
Phase 1 - Qualitative Study:
The audio recordings of the interviews were transcribed. The qualitative data were analyzed using thematic content analysis via MAXQDA 2024 software. The steps of thematic analysis-transcription of the data, creation of codes, identification of themes, and reporting-were systematically followed to develop the context, main themes, and sub-themes. Codes were identified and grouped, which informed the final sub-theme and theme structure.
Sociodemographic characteristics collected during the qualitative phase were analyzed using SPSS version 30.0.0.0 and reported using frequencies and percentages.
Phase 3 - Implementation and Evaluation of the Program:
To assess the adaptation program, the normality of children's scale scores was evaluated using Shapiro-Wilk tests and skewness-kurtosis values. For variables that did not show a normal distribution, median values were reported (see Table 3.14).
The statistical significance of changes in scale scores over time within the sample group was examined using the Friedman test. A significance level of p ≤ 0.05 was accepted for all statistical tests. In cases where a statistically significant difference was found, Bonferroni-adjusted Wilcoxon Signed-Rank Tests were conducted to determine between which measurements the differences occurred, with a significance threshold set at p ≤ 0.01.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: