CancerNCT07713381
Effect of AI-Assisted Expressive Writing on Anxiety, Emotional Distress, and Quality of Life Among Patients Receiving Chemotherapy
A study testing AI-Assisted Expressive Writing and Active Comparator: Routine Care Group in people with Cancer and Chemotherapy, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy, Anxiety
- What is being tested?
- AI-Assisted Expressive Writing and Active Comparator: Routine Care Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2026to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Nursing, Alexandria University
Alexandria, 21511
Mohamed Fakhry Fakhry, PhD, 01286038014, Mohamed.Fakhry@alexu.edu.eg
Mohamed Fakhry Ahmed Salem, PHD
About this study
Official title: 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.
- Conditions
- Cancer, Chemotherapy, Anxiety
- Being tested
- AI-Assisted Expressive Writing, Active Comparator: Routine Care Group
- Keywords
- Artificial Intelligence, AI-Assisted Expressive Writing, Chemotherapy
- Medical subject headings
- Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Expressive WritingBehavioural
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 GroupOther
Participants will receive routine chemotherapy care and standard nursing care provided by the oncology unit without participation in the AI-assisted expressive writing program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AI-Assisted Expressive Writing |
| Routine Care Group | Active comparator | Not described Receives: Other: Active Comparator: Routine Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 1) and Week 4 after intervention
Secondary outcomes (1)
Participants' Experiences with AI-Assisted Expressive Writing
Participants' perceptions and experiences regarding the AI-assisted expressive writing intervention will be explored through semi-structured interviews and analyzed using thematic analysis.
Measured: Week 4 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
- Investigators
- Mohamed Fakhry Ahmed Salem, PHD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713381
- Sponsor's protocol ID
- AIEW-CHEMO-2026
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AI-Assisted Expressive Writing on Anxiety, Emotional Distress, and Quality of Life Among Patients Receiving Chemotherapy: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07713381
- Acronym / sponsor ID
- AIEW-CHEMO-2026
- Conditions
- Cancer, Chemotherapy, Anxiety
- Keywords
- Artificial Intelligence, AI-Assisted Expressive Writing, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Expressive Writing Group | Experimental | Behavioral: AI-Assisted Expressive WritingParticipants 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. |
| Routine Care Group | Active comparator | Other: Active Comparator: Routine Care Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Assisted Expressive WritingParticipants 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. | Behavioural | AI-Assisted Expressive Writing Group |
| Active Comparator: Routine Care GroupParticipants will receive routine chemotherapy care and standard nursing care provided by the oncology unit without participation in the AI-assisted expressive writing program. | Other | Routine Care Group |
Primary outcome
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.
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.
1 secondary outcome
Participants' Experiences with AI-Assisted Expressive Writing
Time frame: Week 4 after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Fakhry Ahmed Salem, PHD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Expressive Writing and Active Comparator: Routine Care Group in people with Cancer and Chemotherapy, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fakhry Ahmed Salem, PhD (+201286038014, Mohamed.Fakhry@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety and Emotional Distress Scores (time frame: Baseline (Day 1) and Week 4 after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.