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

NCT07713381 | Not Yet Recruiting

• 1 other identifier: AIEW-CHEMO-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Chemotherapy; Anxiety

Keywords

Artificial Intelligence; AI-Assisted Expressive Writing; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety and Emotional Distress Scores

  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

  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 Outcomes (1)

• Participants' Experiences with AI-Assisted Expressive Writing

  Week 4 after intervention

Study Arms (2)

AI-Assisted Expressive Writing Group

EXPERIMENTAL

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

Routine Care Group

ACTIVE COMPARATOR

Other: Active Comparator: Routine Care Group

Interventions

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.

Routine Care Group

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.

AI-Assisted Expressive Writing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Nursing, Alexandria University

Alexandria, 21511, Egypt

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mohamed Fakhry Ahmed Salem, PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Fakhry Ahmed Salem, PhD

CONTACT

+201286038014; Mohamed.Fakhry@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Medical-Surgical Nursing

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 20, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)