Evaluation of the Psychosocial Effects of a Trauma-Informed Care-Based Artificial Intelligence-Supported Chatbot in Newly Diagnosed Cancer Patients: A Randomized Controlled Trial
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · TÜBİTAK
interventional
62
0 countries
N/A
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2026
Actual (reported)May 13, 2026
Actual (reported)July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline, 1 and 3 months
Anxiety levels
Baseline, 1 and 3 months
Unmet psychosocial needs
Baseline, 1 and 3 months
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.
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nevra Didem Kılınç, PhD(c)
Koç University
First Submitted
April 29, 2026
First Posted
May 13, 2026
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 30, 2026
Estimated (date passed)Virtual Reality Meditation on Anxiety in Cancer Patients Receiving Chemotherapy
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 13, 2026
Record last verified: 2026-04
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.
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Source: ClinicalTrials.gov.
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