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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Anxiety; Trauma and Stress Related Disorders; Psychosocial Distress
• Intervention / Treatment: Other: Trauma-Informed AI-Supported Chatbot

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nevra Didem Kılınç, PhD(c); Phone Number: +9 0539 436 53 17; Email: nozluk23@ku.edu.tr
• Study Contact Backup: Name: Fahriye Oflaz, Professor; Phone Number: +905445452725; Email: foflaz@ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 and 3 months
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.	Baseline, 1 and 3 months

Collaborators and Investigators

• Sponsor: Koç University
• Collaborators: The Scientific and Technological Research Council of Turkey
• Investigators: Principal Investigator: Nevra Didem Kılınç, PhD(c), Koç University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer diagnosis; trauma-informed care; unmet psychosocial needs; AI-powered chatbot
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Neoplasms; Anxiety Disorders
• Other Study ID Numbers: 2025.468.IRB3.232; 325S436 (Other Grant/Funding Number: TÜBİTAK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No