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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nevra Didem Kılınç, PhD(c)
- 전화번호: +9 0539 436 53 17
- 이메일: nozluk23@ku.edu.tr
연구 연락처 백업
- 이름: Fahriye Oflaz, Professor
- 전화번호: +905445452725
- 이메일: foflaz@ku.edu.tr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
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.
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간섭 없음: 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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Trauma-related distress
기간: 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.
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Baseline, 1 and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anxiety levels
기간: 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.
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Baseline, 1 and 3 months
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Unmet psychosocial needs
기간: Baseline, 1 and 3 months
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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.
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Baseline, 1 and 3 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Nevra Didem Kılınç, PhD(c), Koc University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025.468.IRB3.232
- 325S436 (기타 보조금/기금 번호: TÜBİTAK)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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