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临床试验/NCT07713381
NCT07713381尚未招募不适用

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

Alexandria University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Change in Anxiety and Emotional Distress Scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in Anxiety and Emotional Distress Scores

时间窗: Baseline (Day 1) and Week 4 after intervention

Anxiety and emotional distress will be measured using the Depression Anxiety Stress Scale-21 (DASS-21). Changes in participants' scores will be assessed before and after the intervention. Higher scores indicate greater levels of psychological distress.

Change in Quality of Life Scores

时间窗: Baseline (Day 1) and Week 4 after intervention

Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Changes in quality-of-life scores will be evaluated before and after the intervention.

次要结局

  • Participants' Experiences with AI-Assisted Expressive Writing(Week 4 after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Fakhry Ahmed Salem

Lecturer of Medical-Surgical Nursing

Alexandria University

研究点 (1)

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