Clinical Research Directory
Browse clinical research sites, groups, and studies.
Psychosocial Effects of a Trauma-Informed Artificial Intelligence-Supported Chatbot in Adults Newly Diagnosed With Cancer
Sponsor: Koç University
Summary
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
Official title: Evaluation of the Psychosocial Effects of a Trauma-Informed Care-Based Artificial Intelligence-Supported Chatbot in Newly Diagnosed Cancer Patients: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2026-07-01
Completion Date
2027-01-01
Last Updated
2026-05-13
Healthy Volunteers
No
Interventions
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.