Psychosocial Effects of a Trauma-Informed Artificial Intelligence-Supported Chatbot in Adults Newly Diagnosed With Cancer
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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nevra Didem Kılınç, PhD(c)
- Numéro de téléphone: +9 0539 436 53 17
- E-mail: nozluk23@ku.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Fahriye Oflaz, Professor
- Numéro de téléphone: +905445452725
- E-mail: foflaz@ku.edu.tr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Aucune intervention: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Trauma-related distress
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety levels
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nevra Didem Kılınç, PhD(c), Koc University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025.468.IRB3.232
- 325S436 (Autre subvention/numéro de financement: TÜBİTAK)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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