Resilience, PsychologicalNCT07228533
CesiKids Trial: Enhancing Psychological Resilience in Adolescents With Cancer
A study testing CesiKids Mobile-Based Psychological Resilience Program in people with Resilience, Psychological and Adolescent Cancer, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Resilience, Psychological, Adolescent Cancer, Mobile Application
- What is being tested?
- CesiKids Mobile-Based Psychological Resilience Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine Cebeci Research and Practice Hospital
Ankara, Ankara, 06620
Nurdan TAÇYILDIZ, PhD, +905422353424, tacyildiz@ankara.edu.tr
Sonay İNCESOY ÖZDEMİR, PhD, +905335747519, siozdemir@ankara.edu.tr
About this study
Official title: Evaluation of the Effectiveness of a Nursing-Based Co-Design Intervention Program (CesiKids) to Enhance Psychological Resilience in Hospitalized Adolescents Diagnosed With Cancer: A Randomized Controlled Trial
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.
Read the detailed description
This study aims to develop an innovative mobile-based co-design intervention program to strengthen psychosocial resilience among adolescents aged 12-18 diagnosed with cancer. The program will be structured based on Bronfenbrenner's Ecological Systems Theory, addressing adolescents' individual characteristics, family and close-social environment, and broader ecological interactions in a holistic manner. To date, no study has implemented a theoretically grounded, mobile psychosocial intervention designed specifically to enhance resilience in adolescents with cancer through a co-design process involving nurses, recovered adolescents, and parents. This project aims to fill this gap by presenting a model that can be integrated into both clinical practice and educational settings.
The research will be conducted using a randomized controlled experimental design with intervention and control groups. The intervention group will participate in the newly developed mobile CesiKids program and engage in structured sessions for four weeks to enhance psychosocial resilience skills. The control group will receive standard clinical care. Participants' coping and psychosocial resilience levels will be measured using the Pediatric Cancer Coping Scale (PCCS) and the Child and Youth Resilience Measure (CYRM-R). Data collection will take place at baseline (T0), post-intervention (T1) and during follow-up assessments (T2 and T3). Quantitative data will be analyzed statistically, and the feasibility and usability of the program will also be monitored.
The CesiKids application will be developed by the project leader and research team. Data collection will be carried out by a nurse researcher experienced in pediatric oncology. All intervention, data collection, and analysis procedures will be carefully planned and monitored. All study data will be anonymized and accessible only to the research team. Data will be securely stored on protected servers and maintained throughout the project. All research processes will be conducted in accordance with ethical standards, and participant rights will be fully respected.
The project is expected to generate an evidence-based model that enhances psychosocial resilience among adolescents with cancer. The developed program will be applicable and scalable in both clinical and educational environments. Findings will be disseminated through academic publications, conference presentations, and among relevant healthcare institutions to ensure sustainability and maximize societal impact. Ultimately, this study intends to provide a practical contribution to the field of adolescent psychosocial resilience and to support the adaptation of similar interventions for other chronic illness groups.
- Conditions
- Resilience, Psychological, Adolescent Cancer, Mobile Application, Pediatric Cancer, Pediatric Nursing, Coping
- Being tested
- CesiKids Mobile-Based Psychological Resilience Program
- Keywords
- Adolescent, Resilience, Coping skills, Neoplasms, Pediatric nursing, Mobile application, Psychosocial intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CesiKids Mobile-Based Psychological Resilience ProgramOther
Also called CesiKids Psychological Resilience Intervention, CesiKids Mobile Application, CesiKids Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CesiKids Mobile-Based Psychological Resilience Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The scale was developed by Wu et al. to assess coping strategies among adolescents aged 7-18 diagnosed with cancer. The Turkish validity and reliability study was conducted by Şengül and Törüner with children in the same age range. The scale includes 33 items across three dimensions: cognitive coping, problem-focused coping, and defensive coping. Items are rated on a 0-3 scale, with total scores ranging from 0 to 99. Higher scores indicate stronger coping strategies. The original version showed a Cronbach's alpha of 0.91, while the Turkish version reported 0.77. The scale has been used to assess coping levels in pediatric oncology populations. In this study, it will be used to evaluate the effectiveness of the CesiKids program in enhancing adolescents' coping skills with cancer.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience, PsychologicalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Dağliyar, Eskisehir Osmangazi University
- Investigators
- Ayfer AÇIKGÖZ, PhD, Study director, Eskişehir Osmangazi University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228533
- Sponsor's protocol ID
- ESOGU-SBF-SD-01
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. The dataset contains sensitive clinical and psychological information of adolescent patients with cancer, and data sharing could risk participant identification. Only aggregated and anonymized results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Nursing-Based Co-Design Intervention Program (CesiKids) to Enhance Psychological Resilience in Hospitalized Adolescents Diagnosed With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07228533
- Acronym / sponsor ID
- ESOGU-SBF-SD-01
- Conditions
- Resilience, Psychological, Adolescent Cancer, Mobile Application, Pediatric Cancer, Pediatric Nursing, Coping
- Keywords
- Adolescent, Resilience, Coping skills, Neoplasms, Pediatric nursing, Mobile application, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to develop an innovative mobile-based co-design intervention program to strengthen psychosocial resilience among adolescents aged 12-18 diagnosed with cancer. The program will be structured based on Bronfenbrenner's Ecological Systems Theory, addressing adolescents' individual characteristics, family and close-social environment, and broader ecological interactions in a holistic manner. To date, no study has implemented a theoretically grounded, mobile psychosocial intervention designed specifically to enhance resilience in adolescents with cancer through a co-design process involving nurses, recovered adolescents, and parents. This project aims to fill this gap by presenting a model that can be integrated into both clinical practice and educational settings.
The research will be conducted using a randomized controlled experimental design with intervention and control groups. The intervention group will participate in the newly developed mobile CesiKids program and engage in structured sessions for four weeks to enhance psychosocial resilience skills. The control group will receive standard clinical care. Participants' coping and psychosocial resilience levels will be measured using the Pediatric Cancer Coping Scale (PCCS) and the Child and Youth Resilience Measure (CYRM-R). Data collection will take place at baseline (T0), post-intervention (T1) and during follow-up assessments (T2 and T3). Quantitative data will be analyzed statistically, and the feasibility and usability of the program will also be monitored.
The CesiKids application will be developed by the project leader and research team. Data collection will be carried out by a nurse researcher experienced in pediatric oncology. All intervention, data collection, and analysis procedures will be carefully planned and monitored. All study data will be anonymized and accessible only to the research team. Data will be securely stored on protected servers and maintained throughout the project. All research processes will be conducted in accordance with ethical standards, and participant rights will be fully respected.
The project is expected to generate an evidence-based model that enhances psychosocial resilience among adolescents with cancer. The developed program will be applicable and scalable in both clinical and educational environments. Findings will be disseminated through academic publications, conference presentations, and among relevant healthcare institutions to ensure sustainability and maximize societal impact. Ultimately, this study intends to provide a practical contribution to the field of adolescent psychosocial resilience and to support the adaptation of similar interventions for other chronic illness groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: CesiKids Mobile-Based Psychological Resilience ProgramParticipants 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CesiKids Mobile-Based Psychological Resilience ProgramAlso: CesiKids Psychological Resilience Intervention, CesiKids Mobile Application, CesiKids ProgramThe 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. | Other | CesiKids Intervention Group |
Primary outcome
Child and Youth Resilience Measure (CYRM-R)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention
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.
1 secondary outcome
Pediatric Cancer Coping Scale (PCCS)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. The dataset contains sensitive clinical and psychological information of adolescent patients with cancer, and data sharing could risk participant identification. Only aggregated and anonymized results will be reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayfer AÇIKGÖZ, PhD study director
Eskişehir Osmangazi University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CesiKids Mobile-Based Psychological Resilience Program in people with Resilience, Psychological and Adolescent Cancer, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibel DAĞLIYAR, Master's Degree (PhD Student) (+905065442121, sibel_dagliyar_26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Youth Resilience Measure (CYRM-R) (time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.