Retun-to-school Adaptation Program for Children With Cancer

NCT ID: NCT06389357

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2024-12-06

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.

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.

Conditions

Childhood Cancer; ALL, Childhood; AML, Childhood; Lymphoma; Solid Tumor, Childhood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Implementation and evaluation of the school re-entry adaptation program

Counselling interviews and workshops will be held simultaneously with the children receiving the web-based training. There are 4 modules in total. The first module lasts 2 weeks. The counselling interview will start in the 2nd week. Implementation will be completed in 5 weeks.

Group Type: EXPERIMENTAL

training and counselling

Intervention Type: BEHAVIORAL

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. Separate educational modules have been developed for parents, teachers, and peers.

Interview

Intervention Type: OTHER

As part of the needs assessment in Phase 1, individual interviews with children with cancer and their parents lasting approximately 20-30 minutes were conducted.

Interventions

training and counselling

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. Separate educational modules have been developed for parents, teachers, and peers.

Intervention Type: BEHAVIORAL

Interview

As part of the needs assessment in Phase 1, individual interviews with children with cancer and their parents lasting approximately 20-30 minutes were conducted.

Intervention Type: OTHER

Other Intervention Names

workshops

Eligibility Criteria

Inclusion Criteria

For Children:

Aged between 8 and 17 years Diagnosed with cancer (leukemia, lymphoma, or solid tumor) For children diagnosed with leukemia, currently receiving or having completed maintenance therapy For children diagnosed with other cancer types, treatment has been completed or they are continuing outpatient treatment Have completed the treatment process but have not yet returned to school Have returned to school after treatment but discontinued again due to difficulties managing the adaptation process Have internet access Able to use the internet, computer, and phone Able to speak Turkish Consent to participate in the study

For Parents:

Own a computer or smartphone Have internet access Able to use the internet, computer, and phone Able to speak Turkish Consent to participate in the study

Exclusion Criteria

For Children:

Requiring special physical and/or mental care Having learning disabilities Having a psychological or medical diagnosis (e.g., severe depression) Diagnosed with brain tumor Diagnosed with osteosarcoma Receiving immunosuppressive therapy Experiencing a major stressful event within the past year (e.g., loss, surgery unrelated to cancer treatment) Preparing to take secondary or higher education entrance exams during the study period

For Parents:

Requiring special physical and/or mental care Having learning disabilities Having a psychological or medical diagnosis (e.g., severe depression)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Gizem Çakır

Research Assistant, RN, PhD(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gizem Cakir, PhD

Role: STUDY_CHAIR

Gazi University Nursing Faculty

Locations

Gizem Cakir

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 20705863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26776913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26700927 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22718487 (View on PubMed)

Other Identifiers

1305G2024

Identifier Type: -

Identifier Source: org_study_id