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임상시험 NCT07497256 (DA-BC)은(는) 유방암, 의사결정 보조, 공유 의사결정, 비용 효과성, 삶의 질에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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샤먼 대학Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer : A Multi-Center Randomized Controlled Trial (DA-BC) 160 무작위 배정 다기관
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07497256 (DA-BC)은(는) 유방암, 의사결정 보조, 공유 의사결정, 비용 효과성, 삶의 질에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 4월 1일부터 참여 신청이 가능합니다. 160명의 참여자를 모집할 예정입니다. 샤먼 대학이(가) 진행하는 이 연구는 2027년 10월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
The goal of this multi-center randomized controlled trial is to determine if the clinical decision aid (BCT Aid) works to help breast cancer patients participate in decision-making and make high-quality decisions, thereby improving the rate of breast-conserving surgery and quality of life. The main questions it aims to answer are:
Does the BCT Aid significantly increase the rate of breast-conserving surgery compared...
더 보기상세한 설명
Breast cancer is one of the most common cancers among women in China. More than 90% of breast cancer patients undergo either modified radical mastectomy (mastectomy with or without reconstruction) or breast-conserving surgery (lumpectomy with radiation therapy), with no significant difference in survival outcomes between the two approaches for patients with early-stage breast cancer. The National Comprehensive Cancer...더 보기
공식 제목
Development, Implementation, and Evaluation of a Multimodal Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer Patients: A Multi-Center Randomized Controlled Trial
질환명
유방암의사결정 보조공유 의사결정비용 효과성삶의 질기타 연구 식별자
- DA-BC
- KY-2024-049-H01
- 7231101009 (기타 보조금/자금 번호) (National Natural Science Foundation of China)
NCT 번호
실제 연구 시작일
2026-04
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2027-10
계획된 등록 인원
160
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
breast cancer
decision aid
decision conflict
shared decision making
cost effectiveness
decision aid
decision conflict
shared decision making
cost effectiveness
주요 목적
건강 서비스 연구
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적BCT Aid Intervention Group Participants in this arm will receive a multimodal shared decision-making decision aid (BCT Aid) for 6 months. The BCT Aid includes three module: value model, personalized survival prediction module, and information module. | BCT Aid The BCT Aid is a multimodal shared decision-making decision aid for newly diagnosed breast cancer patients, designed to support patient participation in clinical decision-making and to improve the quality of decisions regarding surgical treatment. It consists of three core components: (1) a values module to elicit patient preferences for surgical options; (2) a personalized survival prediction module to provide indiv...더 보기 |
활성 대조군Usual Care Group Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice. | 일반 치료 Usual care consists of standard clinical consultation and routine information provision as per hospital practice. Patients receive standard care from their healthcare providers, including routine discussions regarding diagnosis, treatment options, and follow-up plans. No additional decision aid or structured shared decision-making intervention will be provided. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Decision conflict | Decision conflict is measured using the Decisional Conflict Scale (DCS), a 16-item instrument that assesses uncertainty in decision-making, factors contributing to uncertainty, and perceived effectiveness of decision-making. Higher scores indicate greater decisional conflict. | At baseline (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (6 months post-intervention) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Decision regret | Decision regret is measured using the Decision Regret Scale (DRS), a 5-item instrument that assesses distress or remorse associated with a healthcare decision. Higher scores indicate greater regret. | At baseline (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (6 months post-intervention) |
Shared Decision-Making | Shared decision-making is measured using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9), which assesses the patient's perceived involvement in the decision-making process. Higher scores indicate a higher level of shared decision-making. | At baseline (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (6 months post-intervention) |
Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) | Quality of life is measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 37-item instrument that assesses physical, social, emotional, and functional well-being, as well as breast cancer-specific concerns. Higher scores indicate better quality of life. | At baseline (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (6 months post-intervention) |
Health-related quality of life | Health-related quality of life is measured using the EQ-5D-5L, a standardized instrument that assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels. The EQ-5D-5L also includes a visual analog scale (EQ-VAS) for self-rated health. Scores are converted into utility values for cost-effectiveness analysis. | Baseline (pre-surgery), 3 months (during intervention period), 6 months (post-intervention), 9 months (3 months post-intervention), 12 months (6 months post-intervention), 15 months (9 months post-intervention), 18 months (12 months post-intervention) |
Breast-conserving surgery rate | Breast-conserving surgery rate is defined as the proportion of participants who undergo breast-conserving surgery. Data on the type of surgery will be collected from medical records. | At 6 months (post-intervention) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
- Age ≥ 18 years.
- Newly diagnosed with breast cancer, with clinical stage 0-II, or stage III patients who have achieved eligibility for breast-conserving surgery after neoadjuvant chemotherapy.
- Clinically eligible for breast-conserving surgery and considering one of the following surgical options: breast-conserving surgery, mastectomy, or mastectomy with reconstruction.
- Clinically eligible for adjuvant therapy after surgery.
- Able to access the internet via smartphone.
- Able to read, speak, and understand Mandarin.
- Male breast cancer patients.
- Patients who are clinically eligible for only one surgical option or who are not candidates for surgery.
- History of other malignancies (except adequately treated cervical carcinoma in situ and treated basal cell carcinoma of the skin).
- Presence of psychiatric disorders, visual or hearing impairments, or cognitive impairment.
샤먼 대학연구 책임자
Jiemin Zhu, 책임연구자, Professor, Xiamen University
연구 대표 연락처
연락처: Jiemin Zhu, +86 15960212649, [email protected]
3 1개국에 임상시험 장소
Fujian
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China
Anqi Qiu, 연락처, +86 15319783286, [email protected]
Anqi Qiu, 책임연구자
Women and Children's Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361003, China
Ying Hua, 연락처, +86 15027022676, [email protected]
Ying Hua, 책임연구자
Xiang'an Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361102, China
Xiaojing Su, 연락처, +86 13023925784, [email protected]
Xiaojing Su, 책임연구자