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NCT Number: NCT07583069

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

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

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Key information

Conditions

Cancer Anxiety Anxiety Disorders Mental Disorders Neoplasms Psychosocial Distress Trauma and Stress Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Trauma-related distress

    Time frame: Baseline, 1 and 3 months

    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.

Secondary outcomes

  1. Anxiety levels

    Time frame: Baseline, 1 and 3 months

    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.

  2. Unmet psychosocial needs

    Time frame: Baseline, 1 and 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fahriye Oflaz, Professor

CONTACT

[email protected]

+905445452725

Nevra Didem Kılınç, PhD(c)

CONTACT

[email protected]

+9 0539 436 53 17

Sponsors and collaborators

Lead sponsor

Koç University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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