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

July 16, 2026 updated by: Mohamed Fakhry Ahmed Salem, Alexandria University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21511
        • Faculty of Nursing, Alexandria University
        • Principal Investigator:
          • Mohamed Fakhry Ahmed Salem, PHD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine Care Group
Other: 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.
Experimental: AI-Assisted Expressive Writing Group
Participants in this group will receive routine chemotherapy care in addition to the AI-assisted expressive writing program. The intervention will be delivered through guided writing sessions using an artificial intelligence platform designed to facilitate emotional expression and reflection.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) and Week 4 after intervention
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.
Baseline (Day 1) and Week 4 after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4 after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Fakhry Ahmed Salem, PHD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 10, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

September 10, 2026

Study Registration Dates

First Submitted

July 5, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIEW-CHEMO-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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