Clinical trial NCT06389357: Return to School Adaptation Programme for Children With Cancer
Official title: Efficacy of the Web-based Return to School Adaptation Programme for Children With Cancer: a Meta-theory-based Action Research
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Childhood Cancer
ALL, Childhood
AML, Childhood
Lymphoma
Solid Tumor, Childhood
Keywords: childhood cancer
return to school
adaptation
web-based programme
meta-theory-based
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 35
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The research is a technical/scientific/collaborative action research design.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: social anxiety
timeFrame: before and after the intervention, 1st month and 3rd month after starting school
measure: coping
timeFrame: before and after the intervention, 1st month and 3rd month after starting school
measure: back to school readiness
timeFrame: before and after the intervention, 1st month and 3rd month after starting school
Secondary outcomes:
measure: process evaluation
timeFrame: 1st month and 3rd month after starting school
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gizem Cakir
state: Cankaya
Study officials:
affiliation: Gazi University Nursing Faculty
name: Gizem Cakir, PhD(c)
role: STUDY_CHAIR
References:
citation: Crisan A, Elliott M. How to evaluate an evaluation study? Comparing and contrasting practices in vis with those of other disciplines. IEEE Xplore. 2018; doi: 10.1109/BELIV.2018.8634420.
citation: Rabin C, Simpson N, Morrow K, Pinto B. Behavioral and psychosocial program needs of young adult cancer survivors. Qual Health Res. 2011 Jun;21(6):796-806. doi: 10.1177/1049732310380060. Epub 2010 Aug 12.
citation: Ellis SJ, Wakefield CE, Antill G, Burns M, Patterson P. Supporting children facing a parent's cancer diagnosis: a systematic review of children's psychosocial needs and existing interventions. Eur J Cancer Care (Engl). 2017 Jan;26(1). doi: 10.1111/ecc.12432. Epub 2016 Jan 18.
citation: Thompson AL, Christiansen HL, Elam M, Hoag J, Irwin MK, Pao M, Voll M, Noll RB, Kelly KP. Academic Continuity and School Reentry Support as a Standard of Care in Pediatric Oncology. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5(Suppl 5):S805-17. doi: 10.1002/pbc.25760.
citation: Canter KS, Roberts MC. A systematic and quantitative review of interventions to facilitate school reentry for children with chronic health conditions. J Pediatr Psychol. 2012 Nov-Dec;37(10):1065-75. doi: 10.1093/jpepsy/jss071. Epub 2012 Jun 19.