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

Официальное название

Evaluation of the Psychosocial Effects of a Trauma-Informed Care-Based Artificial Intelligence-Supported Chatbot in Newly Diagnosed Cancer Patients: A Randomized Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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 d

Первичные конечные точки

• Trauma-related distress [Срок оценки: Baseline, 1 and 3 months]

Вторичные конечные точки (2)

• Anxiety levels [Срок оценки: Baseline, 1 and 3 months]
• Unmet psychosocial needs [Срок оценки: Baseline, 1 and 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07583069 · 2025.468.IRB3.232 · 325S436

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗