Return to School Adaptation Programme for Children With Cancer

Trial Title: Return to School Adaptation Programme for Children With Cancer

NCT ID: NCT06389357

Condition: Childhood Cancer
ALL, Childhood
AML, Childhood
Lymphoma
Solid Tumor, Childhood

Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Conditions: Keywords:
childhood cancer
return to school
adaptation
web-based programme
meta-theory-based

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: The research is a technical/scientific/collaborative action research design.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: training and counselling
Description: It includes 4 modules that develop children's communication, coping and social life skills and psychosocial preparation for the return to school process. The modules include theoretical explanations, stories, workshops and counselling sessions.
Arm group label: return to school adaptation program

Other name: workshops

Summary: This study is planned to evaluate the effect of back-to-school adaptation programme on social anxiety score, coping score and back-to-school readiness score in children aged 8-17 years who are followed up with a diagnosis of cancer. H1: Is there a significant difference in children's social anxiety scores before and after the back-to-school adaptation programme? H2: Is there a significant difference in children's coping scores before and after the back-to-school adaptation programme? H3: Is there a significant difference in children's readiness to return to school scores before and after the back-to-school adaptation programme?

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 The research will be conducted with a single group. In a publication on programme evaluation studies, it is recommended that the eta square should be at least 0.06 and 85% power. Based on this information, the sample size estimated by G*Power analysis with 85% power and 5% margin of error is 26. Although there is no similar study in the literature in terms of method and measurement tools, it is seen that case loss is between 16-32% in studies conducted with similar populations within the scope of back-to-school intervention. For this reason, the calculated sample size was increased by 32% and the sample size was determined as 35. Data Collection Tools The following forms were planned to be used in data collection. 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 The data obtained from the research will be evaluated in SPSS 29.0 package data programme. In the analysis of the data, independent groups t-test will be applied for sociodemographic data with normal distribution. In the comparison of the measurements before and after the implementation of the back-to-school adaptation programme to the group, t-test will be used for parametric assumptions, and Wilcoxon signed-rank test will be used when parametric assumptions cannot be met. In order to measure the statistical significance of dependent groups, one-factor analysis of variance will be used if parametric assumptions are met, Friedman analysis of variance will be used if parametric assumptions are not met. The significance level for descriptive statistics is p<0.05. Thematic content analysis method will be used in the evaluation of qualitative data.

Criteria for eligibility:
Criteria:
Inclusion Criteria: For children - Between the ages of 8-17 - Diagnosed with cancer (leukaemia, lymphoma, solid tumour) - Receiving or have received maintenance treatment for children diagnosed with leukaemia - Children diagnosed with other types of cancer have completed treatment or are continuing outpatient treatment - Not starting school after the diagnosis and treatment process - Having started school after the diagnosis and treatment process and being absent again because the adaptation process could not be managed - Having internet access - Ability to use the Internet, computer and telephone - Ability to speak Turkish - Acceptance to participate in the study For parents; - Having a computer or smartphone - Having internet access - Ability to use the Internet, computer and telephone - Ability to speak Turkish - Acceptance to participate in the study Exclusion Criteria: - Physical and/or mental special care needs - Learning difficulties - Having a psychological medical diagnosis (severe depression, etc.) - Diagnosed with a brain tumour - Diagnosed with osteosarcoma - Receiving immunosuppressive therapy - Having experienced a major stress situation in the last year (such as loss, undergoing a surgical operation for a reason other than cancer treatment) - To take secondary and higher education exams in the period when the study will be conducted

Gender: All

Minimum age: 8 Years

Maximum age: 17 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gizem Cakir

Address:
City: Ankara
Zip: 06490
Country: Turkey

Start date: July 2, 2024

Completion date: November 30, 2024

Lead sponsor:
Agency: Gazi University
Agency class: Other

Source: Gazi University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06389357