CesiKids Trial: Enhancing Psychological Resilience in Adolescents With Cancer

NCT07228533 | Not Yet Recruiting

• 1 other identifier: ESOGU-SBF-SD-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and evaluate a mobile-based co-design intervention (CesiKids) to enhance psychosocial resilience in hospitalized adolescents aged 12-18 diagnosed with cancer. The program will be created using Bronfenbrenner's Ecological Systems Theory and designed in collaboration with nurses, recovered adolescents, and parents. A randomized controlled design will be used. The intervention group will participate in a four-week structured program, while the control group will receive standard care. Psychosocial resilience and coping outcomes will be assessed at baseline, post-intervention, and follow-up. This research aims to offer an evidence-based, scalable model to support resilience among adolescents with cancer in clinical settings.

Conditions

Resilience, Psychological; Adolescent Cancer; Mobile Application; Pediatric Cancer; Pediatric Nursing; Coping

Keywords

Adolescent; Resilience; Coping skills; Neoplasms; Pediatric nursing; Mobile application; Psychosocial intervention

Outcome Measures

Primary Outcomes (1)

• Child and Youth Resilience Measure (CYRM-R)

  The Child and Youth Resilience Measure-Revised (CYRM-R) is a multidimensional scale based on the socio-ecological model to assess resilience. The 28-item original version was developed by Liebenberg, Ungar, and Van de Vijver through the International Resilience Project. Later, Liebenberg, Ungar, and LeBlanc created a 12-item short form with three subscales: individual, relational, and contextual resilience. Factor loadings ranged from .39-.88, and Cronbach's alpha was .84. Items are rated on a five-point Likert scale (1-5), with higher scores indicating greater resilience. The Turkish adaptation by Arslan showed strong reliability (α = .91; item-total correlations = .45-.79). In this study, the CYRM-R will assess changes in adolescents' resilience after the CesiKids program.

  Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention

Secondary Outcomes (1)

• Pediatric Cancer Coping Scale (PCCS)

  Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention

Study Arms (2)

Standard Psychosocial Care Group

NO INTERVENTION

Participants in this arm will receive standard psychological care routinely provided within the pediatric oncology clinic. No additional structured digital intervention or psychological resilience-based program will be administered. Standard support, including routine clinical communication and psychological services offered by the healthcare team, will continue as usual during the study period.

CesiKids Intervention Group

EXPERIMENTAL

Participants in this group will receive the CesiKids program, a mobile-based psychological resilience intervention specifically developed for adolescents diagnosed with cancer. The program includes AI-supported guidance and interventions and consists of a total of four modules delivered over four weeks, with two structured sessions per module (eight sessions in total). Participants' engagement with the program and their assessment outcomes will be evaluated to determine the feasibility and effectiveness of the CesiKids intervention in enhancing psychological resilience and coping skills among adolescents with cancer.

Other: CesiKids Mobile-Based Psychological Resilience Program

Interventions

CesiKids Mobile-Based Psychological Resilience Program OTHER

The CesiKids Program will be a nurse-led, AI-supported mobile intervention to enhance psychological resilience in adolescents diagnosed with cancer. Grounded in Bronfenbrenner's Bioecological Theory, it will address interactions between adolescents and their family, peers, and clinical environments. Developed through a co-design process with nurses, recovered adolescents, and parents, the program will include AI-driven adaptive feedback and emotional support features. Delivered over four weeks with structured digital sessions, CesiKids will promote emotional regulation, coping, and resilience through interactive storytelling, reflection, and personalized guidance. This integrative model will combine ecological principles, AI personalization, and participatory design to create an innovative psychosocial care approach for hospitalized adolescents with cancer.

Also known as: CesiKids Psychological Resilience Intervention, CesiKids Mobile Application, CesiKids Program

CesiKids Intervention Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parents have provided informed consent after receiving information,
• The child has given assent to participate after being informed,
• The child is between 12 and 18 years of age,
• The child has been diagnosed with cancer and is currently receiving inpatient treatment,
• The child is undergoing chemotherapy and/or radiotherapy,
• The child is able to use a computer and/or smartphone,
• The child can understand and speak Turkish.

You may not qualify if:

• Receiving hematopoietic stem cell transplantation treatment,
• Having developed a relapse after remission,
• Experiencing communication difficulties (e.g., intellectual disability, visual impairment, etc.),
• Having a psychiatric diagnosis made by a psychiatrist,
• Having experienced a significant life event affecting psychological well-being within the past four weeks (e.g., death, divorce, etc.).

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Ankara University Faculty of Medicine Cebeci Research and Practice Hospital

Ankara, Ankara, 06620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ayfer AÇIKGÖZ, PhD

  Eskişehir Osmangazi University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Sibel DAĞLIYAR, Master's Degree (PhD Student)

CONTACT

+905065442121; sibel_dagliyar_26@hotmail.com

Ayfer AÇIKGÖZ, PhD

CONTACT

+905352919374; ayferacikgozayfer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the study will be conducted by the principal investigator, investigator blinding will not be possible. Additionally, because the study will be carried out with hospitalized adolescents and the intervention and control groups will be present in the clinic simultaneously, participant blinding cannot be implemented. To prevent potential bias in group allocation, the randomization table will be generated by an independent statistician. Data analysis and reporting will also be conducted by the same independent statistician, ensuring blinding at the statistical analysis stage.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: This study is a randomized controlled trial with a parallel assignment design. Participants will be randomly assigned to either the intervention or control group and followed concurrently. Adolescents in the intervention group will participate in the four-week CesiKids mobile psychosocial resilience program, while the control group will receive standard clinical care. No crossover between groups will occur.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)