Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Psychosocial Distress | — | UNRESOLVED | — |
| Trauma and Stress Related Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trauma-Informed AI-Supported Chatbot | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chatbot
- description
- 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.
- interventionNames
- Other: Trauma-Informed AI-Supported Chatbot
- type
- NO_INTERVENTION
- label
- Control
- description
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available