Childhood Cancerweb-basedNCT06389357
Retun-to-school Adaptation Program for Children With Cancer
A study testing training and counselling and Interview in people with Childhood Cancer and ALL, Childhood, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Childhood Cancer, ALL, Childhood, AML, Childhood
- What is being tested?
- training and counselling and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 6 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Web-based Return-to-school Adaptation Program for Children Diagnosed With Cancer
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.
Read the 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:
- Child and Parent Descriptive Information Form
- Data Collection Form for Children's Return to School Process
- Social Anxiety Scale for Children-Revised Version
- Social Anxiety Scale for Adolescents
- Paediatric Cancer Coping Scale
- Readiness to Return to School Scale for Children with Oncological Problems: 7-18 Age
- 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.
- Being tested
- training and counselling, Interview
- Keywords
- childhood cancer, return to school, web-based programme, Got Transition, transition care, adaptation program, pediatric nursing, social anxiety, coping, readinness to return to school, Transition Theory
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training and counsellingBehavioural
Also called workshops
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.
InterviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation and evaluation of the school re-entry adaptation program | Experimental | 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. Receives: Behavioral: training and counselling; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
social anxiety
Social anxiety scale fo children-revised. Scores that can be obtained from the scale are between 18-90 and as the scale score increases, the level of social anxiety increases.
Measured: Before the intervention, before starting school, one month after starting school, three months after starting school
coping
Paediatric Cancer Coping Scale. Scores that can be obtained from the scale are between 0-99 and coping strategies increase as the scale score increases.
Measured: Before the intervention, before starting school, one month after starting school, three months after starting school
back to school readiness
Back to school readiness scale for children with oncological problems: 7-18 years of age. The score that can be obtained from the scale is between 0 and 152 and a higher score indicates an increase in school readiness.
Measured: Before the intervention, before starting school, one month after starting school, three months after starting school
Secondary outcomes (1)
process evaluation
Return to School Process Data Collection Form
Measured: 1st month and 3rd month after starting school
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start30 May 2023
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The research is a technical/scientific/collaborative action research design.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Çakır, Gazi University
- Investigators
- Gizem Cakir, PhD, Study chair, Gazi University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389357
- Sponsor's protocol ID
- 1305G2024
- Acronym
- web-based
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared with other researchers. Since the data is individual, it is not ethically appropriate.
Publications
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.
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.
PubMed 20705863Ellis 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.
PubMed 26776913Thompson 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.
PubMed 26700927Canter 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.
PubMed 22718487