Psychosocial Effects of a Trauma-Informed Artificial Intelligence-Supported Chatbot in Adults Newly Diagnosed With Cancer

NCT07583069 | Not Yet Recruiting

• 2 other identifiers: 2025.468.IRB3.232325S436
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cancer; Psychosocial Distress; Trauma and Stress Related Disorders; Anxiety

Keywords

cancer diagnosis; unmet psychosocial needs; trauma-informed care; AI-powered chatbot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety levels

  Baseline, 1 and 3 months

• Unmet psychosocial needs

  Baseline, 1 and 3 months

Study Arms (2)

Chatbot

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Trauma-Informed AI-Supported Chatbot OTHER

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.

Chatbot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Neoplasms; Trauma and Stressor Related Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nevra Didem Kılınç, PhD(c)

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nevra Didem Kılınç, PhD(c)

CONTACT

+9 0539 436 53 17; nozluk23@ku.edu.tr

Fahriye Oflaz, Professor

CONTACT

+905445452725; foflaz@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share