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Università di XiamenShared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer : A Multi-Center Randomized Controlled Trial (DA-BC) 160 Randomizzato Multicentrico
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07497256 (DA-BC) è uno studio interventistico per Cancro al seno, Strumento di supporto decisionale, Decisione condivisa, Efficacia dei costi, Qualità della vita, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 aprile 2026, con l'obiettivo di raggiungere 160 partecipanti. Sotto la guida di l'Università di Xiamen, dovrebbe concludersi entro il 1 ottobre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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...
Mostra di piùDescrizione dettagliata
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...Mostra di più
Titolo ufficiale
Development, Implementation, and Evaluation of a Multimodal Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer Patients: A Multi-Center Randomized Controlled Trial
Patologie
Cancro al senoStrumento di supporto decisionaleDecisione condivisaEfficacia dei costiQualità della vitaAltri ID dello studio
- DA-BC
- KY-2024-049-H01
- 7231101009 (Altro numero di finanziamento) (National Natural Science Foundation of China)
Numero NCT
Data di inizio (effettiva)
2026-04
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-10
Arruolamento (previsto)
160
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
breast cancer
decision aid
decision conflict
shared decision making
cost effectiveness
decision aid
decision conflict
shared decision making
cost effectiveness
Scopo principale
Ricerca sui servizi sanitari
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleBCT 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...Mostra di più |
Comparatore attivoUsual Care Group Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice. | Cura abituale 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Femmina
- 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.
Università di Xiamen153 studi clinici attivi da esplorareParte responsabile dello studio
Jiemin Zhu, Investigatore principale, Professor, Xiamen University
Contatti principali dello studio
Contatto: Jiemin Zhu, +86 15960212649, [email protected]
3 Centri dello studio in 1 paesi
Fujian
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China
Anqi Qiu, Contatto, +86 15319783286, [email protected]
Anqi Qiu, Investigatore principale
Women and Children's Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361003, China
Ying Hua, Contatto, +86 15027022676, [email protected]
Ying Hua, Investigatore principale
Xiang'an Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361102, China
Xiaojing Su, Contatto, +86 13023925784, [email protected]
Xiaojing Su, Investigatore principale