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Набор скоро начнётся NCT07713381

Effect of AI-Assisted Expressive Writing on Anxiety, Emotional Distress, and Quality of Life Among Patients Receiving Chemotherapy

Без фазы С лечением Cancer Chemotherapy Anxiety

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: AI-Assisted Expressive Writing, Active Comparator: Routine Care Group.
Кому может быть актуально
Состояния в реестре: Cancer, Chemotherapy, Anxiety. Базовые параметры: от 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of AI-Assisted Expressive Writing on Anxiety, Emotional Distress, and Quality of Life Among Patients Receiving Chemotherapy: A Mixed-Methods Study

Обзор

This study aims to evaluate the effect of an AI-assisted expressive writing intervention on anxiety, emotional distress, and quality of life among patients receiving chemotherapy. A mixed-methods, interventional research design will be employed. Participants will be assigned to either a study group receiving the AI-assisted expressive writing program in addition to routine care or a control group receiving routine care only. Quantitative data will be collected using the Depression Anxiety Stress Scale-21 (DASS-21) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Qualitative data will be obtained through semi-structured interviews to explore participants' experiences with the intervention. The findings are expected to provide evidence regarding the effectiveness of AI-assisted expressive writing as a supportive strategy for improving psychological well-being and quality of life among patients undergoing chemotherapy.

Вмешательства

  • Поведенческое AI-Assisted Expressive Writing
    Participants will engage in an AI-assisted expressive writing program in addition to routine chemotherapy care. The intervention consists of guided writing sessions delivered through an artificial intelligence platform that provides structured prompts to facilitate emotional expression, self-reflection, and disclosure of thoughts and feelings related to cancer and chemotherapy experiences.
  • Другое Active Comparator: Routine Care Group
    Participants will receive routine chemotherapy care and standard nursing care provided by the oncology unit without participation in the AI-assisted expressive writing program.

Первичные конечные точки

  • Change in Anxiety and Emotional Distress Scores [Срок оценки: Baseline (Day 1) and Week 4 after intervention]
  • Change in Quality of Life Scores [Срок оценки: Baseline (Day 1) and Week 4 after intervention]
Вторичные конечные точки (1)
  • Participants' Experiences with AI-Assisted Expressive Writing [Срок оценки: Week 4 after intervention]

Критерии участия

Критерии включения

  • Adult patients aged 18 years and above.
  • Diagnosed with any type of cancer and currently receiving chemotherapy treatment.
  • Able to read and write Arabic.
  • Able to communicate and express thoughts and feelings.
  • Have access to a smartphone, tablet, or computer with internet connectivity.
  • Willing to participate in the study and provide informed consent.

Критерии исключения

  • Diagnosed with severe psychiatric disorders (e.g., psychosis or schizophrenia).
  • Having cognitive impairment that interferes with understanding or communication.
  • Currently receiving structured psychological therapy during the study period.
  • Unable to complete the study questionnaires or intervention sessions.
  • Refusal to participate or withdrawal from the study at any time.

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Египет · 1 центр
  • Faculty of Nursing, Alexandria University — Alexandria

Идентификаторы

NCT: NCT07713381 · AIEW-CHEMO-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗