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
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),
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.
Parallel
Trauma-Informed AI-Supported Chatbot
Other interventionThe 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.
Trauma-related distress
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.
Anxiety levels
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.
Unmet psychosocial needs
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.
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Koç University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
