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NCT Number: NCT07713381

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

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.

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Key information

Conditions

Cancer Anxiety Anxiety Disorders Chemotherapy Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing, Alexandria University

Alexandria, 21511, Egypt

Location contact

Mohamed Fakhry Ahmed Salem, PHD

PRINCIPAL_INVESTIGATOR

Mohamed Fakhry Fakhry, PhD

CONTACT

[email protected]

01286038014

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AI-Assisted Expressive Writing

Behavioral

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.

Active Comparator: Routine Care Group

Other

Participants will receive routine chemotherapy care and standard nursing care provided by the oncology unit without participation in the AI-assisted expressive writing program.

Primary outcomes

  1. Change in Anxiety and Emotional Distress Scores

    Time frame: 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.

  2. Change in Quality of Life Scores

    Time frame: 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.

Secondary outcomes

  1. Participants' Experiences with AI-Assisted Expressive Writing

    Time frame: Week 4 after intervention

    Participants' perceptions and experiences regarding the AI-assisted expressive writing intervention will be explored through semi-structured interviews and analyzed using thematic analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Fakhry Ahmed Salem, PhD

CONTACT

[email protected]

+201286038014

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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