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Набор скоро начнётся NCT07228533

CesiKids Trial: Enhancing Psychological Resilience in Adolescents With Cancer

Без фазы С лечением Resilience, Psychological Adolescent Cancer Mobile Application Pediatric Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CesiKids Mobile-Based Psychological Resilience Program.
Кому может быть актуально
Состояния в реестре: Resilience, Psychological, Adolescent Cancer, Mobile Application, Pediatric Cancer. Базовые параметры: 12 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое CesiKids Mobile-Based Psychological Resilience 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 w

Первичные конечные точки

  • Child and Youth Resilience Measure (CYRM-R) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention]
Вторичные конечные точки (1)
  • Pediatric Cancer Coping Scale (PCCS) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week after completion), 3 months post-intervention, and 6 months post-intervention]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara University Faculty of Medicine Cebeci Research and Practice Hospital — Ankara

Идентификаторы

NCT: NCT07228533 · ESOGU-SBF-SD-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗