- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07713381
Effect of AI-Assisted Expressive Writing on Anxiety, Emotional Distress, and Quality of Life Among Patients Receiving Chemotherapy
16. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mohamed Fakhry Ahmed Salem, PhD
- Telefonnummer: +201286038014
- E-mail: Mohamed.Fakhry@alexu.edu.eg
Studiesteder
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Alexandria, Egypten, 21511
- Faculty of Nursing, Alexandria University
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Ledende efterforsker:
- Mohamed Fakhry Ahmed Salem, PHD
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Kontakt:
- Mohamed Fakhry Fakhry, PhD
- Telefonnummer: 01286038014
- E-mail: Mohamed.Fakhry@alexu.edu.eg
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Routine Care Group
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Participants will receive routine chemotherapy care and standard nursing care provided by the oncology unit without participation in the AI-assisted expressive writing program.
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Anxiety and Emotional Distress Scores
Tidsramme: Baseline (Day 1) and Week 4 after intervention
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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.
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Baseline (Day 1) and Week 4 after intervention
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Change in Quality of Life Scores
Tidsramme: Baseline (Day 1) and Week 4 after intervention
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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.
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Baseline (Day 1) and Week 4 after intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Participants' Experiences with AI-Assisted Expressive Writing
Tidsramme: Week 4 after intervention
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Participants' perceptions and experiences regarding the AI-assisted expressive writing intervention will be explored through semi-structured interviews and analyzed using thematic analysis.
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Week 4 after intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mohamed Fakhry Ahmed Salem, PHD, Alexandria University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. juli 2026
Primær færdiggørelse (Anslået)
10. august 2026
Studieafslutning (Anslået)
10. september 2026
Datoer for studieregistrering
Først indsendt
5. juli 2026
Først indsendt, der opfyldte QC-kriterier
16. juli 2026
Først opslået (Faktiske)
20. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AIEW-CHEMO-2026
Plan for individuelle deltagerdata (IPD)
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