NCT06389357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
Last Updated

September 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

April 24, 2024

Last Update Submit

September 23, 2025

Conditions

Keywords

childhood cancerreturn to schoolweb-based programmeGot Transitiontransition careadaptation programpediatric nursingsocial anxietycopingreadinness to return to schoolTransition Theory

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Before the intervention, before starting school, one month after starting school, three months after starting school

Secondary Outcomes (1)

  • process evaluation

    1st month and 3rd month after starting school

Study Arms (1)

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.

Behavioral: training and counsellingOther: Interview

Interventions

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.

Also known as: workshops
Implementation and evaluation of the school re-entry adaptation program

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.

Implementation and evaluation of the school re-entry adaptation program

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gizem Cakir

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    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.

    PMID: 20705863BACKGROUND
  • 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.

    PMID: 26776913BACKGROUND
  • 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.

    PMID: 26700927BACKGROUND
  • 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.

    PMID: 22718487BACKGROUND

MeSH Terms

Conditions

NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLymphoma

Interventions

CounselingInterviews as Topic

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gizem Cakir, PhD

    Gazi University Nursing Faculty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The research is a technical/scientific/collaborative action research design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, RN, PhD(c)

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

May 30, 2023

Primary Completion

December 6, 2024

Study Completion

December 6, 2024

Last Updated

September 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

individual participant data will not be shared with other researchers. Since the data is individual, it is not ethically appropriate.

Locations