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Psychosocial Effects of a Trauma-Informed Artificial Intelligence-Supported Chatbot in Adults Newly Diagnosed With Cancer

7. Mai 2026 aktualisiert von: Koç University

Evaluation of the Psychosocial Effects of a Trauma-Informed Care-Based Artificial Intelligence-Supported Chatbot in Newly Diagnosed Cancer Patients: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether a trauma-informed, artificial intelligence-supported chatbot can reduce psychological distress and unmet psychosocial needs in adults newly diagnosed with cancer.:

  • Does the chatbot reduce trauma-related distress and anxiety levels compared to standard care?
  • Does the chatbot decrease unmet psychosocial needs in patients following a new cancer diagnosis? Researchers will compare the chatbot intervention to standard care to determine whether the chatbot provides additional psychosocial benefit.

Participants will:

  • Be randomly assigned to either the chatbot intervention group or the standard care group
  • Use the chatbot freely for 12 weeks (intervention group only)
  • Complete questionnaires at baseline, 1 month, and 3 months
  • Be monitored for any psychological risk indicators during the study period

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Receiving a cancer diagnosis is a potentially traumatic experience associated with significant psychological distress, anxiety, and unmet psychosocial needs. Despite the recognized importance of psychosocial care in oncology, barriers such as limited healthcare resources, heavy workload, and insufficient access to timely support may prevent patients from receiving adequate psychosocial interventions during the early stages following diagnosis.

Trauma-Informed Care (TIC) is an approach that recognizes the psychological impact of traumatic experiences and aims to provide support through principles including safety, trustworthiness, empowerment, collaboration, and cultural sensitivity. Integrating TIC principles into digital health interventions may provide accessible and individualized psychosocial support for patients newly diagnosed with cancer.

This study aims to evaluate the effectiveness of a trauma-informed, artificial intelligence-supported chatbot developed to provide early psychosocial support to adults newly diagnosed with cancer. The chatbot is designed to deliver empathetic and supportive interactions grounded in trauma-informed care principles. It provides psycho-education, emotional support, coping facilitation, and guidance toward professional support resources when needed, without offering medical diagnosis or treatment recommendations.

The study is designed as a randomized controlled trial consisting of an intervention group receiving access to the chatbot in addition to standard care and a control group receiving standard care alone. Outcomes related to trauma-related distress, anxiety and psychosocial needs will be evaluated over a 12-week period.

The chatbot system incorporates predefined safety mechanisms and interaction-based monitoring to identify potential psychological risk indicators during use. Participants identified as potentially at risk may be directed toward appropriate professional support resources according to the study safety protocol.

Studientyp

Interventionell

Einschreibung (Geschätzt)

62

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Nevra Didem Kılınç, PhD(c)
  • Telefonnummer: +9 0539 436 53 17
  • E-Mail: nozluk23@ku.edu.tr

Studieren Sie die Kontaktsicherung

  • Name: Fahriye Oflaz, Professor
  • Telefonnummer: +905445452725
  • E-Mail: foflaz@ku.edu.tr

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Over 18 years of age,
  • Able to speak and understand Turkish,
  • Without any cognitive, visual, or auditory impairments,
  • Diagnosed with cancer within the last month (Stage I, II, and III) (regardless of cancer type),
  • Have started active cancer treatment,
  • Have access to a digital device and the internet,
  • Volunteer to participate in the study will be included.

Exclusion Criteria:

  • Patients participating in another simultaneous psychosocial/digital intervention study,
  • Patients diagnosed with advanced stage (Stage IV) cancer, in the terminal phase and with metastases,
  • Patients diagnosed with schizophrenia, bipolar disorder, substance abuse, depression and anxiety disorders will be excluded.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Chatbot
Participants in this arm will receive access to a trauma-informed, artificial intelligence-supported chatbot designed to provide psychosocial support following a new cancer diagnosis. The chatbot allows free-text interaction and is available for use over a 12-week period. It is designed in line with trauma-informed care principles and provides emotional support, coping facilitation, and guidance toward professional help when needed. Participants will also receive standard care. Chatbot interactions will be monitored for potential psychological risk indicators, and appropriate guidance will be provided if risk is detected.
Sonstiges: Trauma-Informed AI-Supported Chatbot
The intervention consists of a trauma-informed, AI-supported chatbot designed to provide psychosocial support to adults newly diagnosed with cancer. The chatbot is grounded in trauma-informed care principles, including safety, trustworthiness, empowerment, collaboration, and sensitivity to emotional distress following diagnosis. It enables free-text, user-initiated conversations and delivers empathetic, non-directive support aimed at facilitating emotional expression, coping, and adaptation to diagnosis. The chatbot does not provide medical, pharmacological, nutritional, or exercise advice. Instead, it focuses on psychosocial support and encourages users to seek professional help when appropriate. The system incorporates predefined safety rules and continuous interaction-based risk monitoring; when indicators of psychological risk are detected, users are guided toward appropriate support resources. Participants are granted access to the chatbot for a 12-week period.
Kein Eingriff: Control
Participants in this arm will receive standard care as routinely provided by the institution. No chatbot intervention will be provided during the study period. Participants may access usual psychosocial or clinical support services as needed

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Trauma-related distress
Zeitfenster: Baseline, 1 and 3 months
Trauma-related distress associated with cancer diagnosis will be assessed using the Impact of Event Scale-Revised (IES-R). The IES-R is a validated self-report instrument measuring intrusion, avoidance, and hyperarousal symptoms. Total scores range from 0 to 88, with higher scores indicating greater trauma-related distress.
Baseline, 1 and 3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anxiety levels
Zeitfenster: Baseline, 1 and 3 months
Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which assesses both state and trait anxiety levels. Scores for each sub-scale range from 20 to 80, with higher scores indicating higher anxiety levels.
Baseline, 1 and 3 months
Unmet psychosocial needs
Zeitfenster: Baseline, 1 and 3 months
Psychosocial needs will be assessed using the Psychosocial Needs Inventory (PNI), a 48-item scale evaluating the importance and fulfillment of psychosocial needs across multiple domains. Items are scored on a 1-5 Likert scale. Higher scores indicate greater perceived importance and/or better fulfillment of psychosocial needs.
Baseline, 1 and 3 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Koç University

Mitarbeiter

The Scientific and Technological Research Council of Turkey

Ermittler

  • Hauptermittler: Nevra Didem Kılınç, PhD(c), Koç University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

30. Oktober 2026

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025.468.IRB3.232
  • 325S436 (Andere Zuschuss-/Finanzierungsnummer: TÜBİTAK)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be made publicly available due to the sensitive nature of psychosocial data collected from patients newly diagnosed with cancer and to ensure participant confidentiality.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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