Impact of a Personalized and Secure Video Information Support and Web Platform on Preoperative Anxiety in the Context of Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 8
- 主要终点
- Rate of patients with perioperative anxiety symptoms
研究概览
简要总结
The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient.
There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of breast surgery and allows the patient to have access to information on surgical management at any time.
The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.
详细描述
The medical information provided during the pre-operative phase is an essential and mandatory step in the duty to inform during the initial management of the patient undergoing surgery. The different reasons acting on the quantity and quality of the medical information integrated by the patient can be linked to several factors: among others, the information supports, the age, the listening and comprehension capacities, the level of anxiety or the level of education of the patient, thus creating health inequalities. The use of visual communication seems to be more suitable for patients with a low level of education, illiteracy or non-native speakers. Studies have shown that, in addition to oral preoperative information, the introduction of a visual medium with the use of a video has demonstrated a significant reduction in preoperative anxiety and the use of the Internet.
The prevalence of anxiety is high in cancer patients, particularly during the preoperative phase. The EDOP company has developed a personalized and secure Internet platform containing, among other things, an explanatory video on breast surgery. In the current literature, there are no studies on the contribution of the use of video and web platform in the context of preoperative medical information.
In this study, the investigators hypothesize that the unlimited access to the EDOP platform and the possibility to review as many times as necessary the information concerning their surgical intervention could allow, whatever the situation of the patients, to reduce the level of preoperative anxiety, which is always deleterious. Indeed, studies have shown the negative effects of preoperative anxiety on the quantity of anaesthetic used during the operation or on the consumption of analgesics postoperatively. A reduction in preoperative anxiety would therefore be likely to lead in the short term to a reduction in drug treatments and probably to a better state of health.
The main objective is to evaluate the impact of additional personalized preoperative medical information, accessible via a secure internet platform, on anxiety on the morning of surgery, in the context of breast cancer surgery, after conventional oral and written information.
The secondary objectives are to compare between the 2 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Only the clinical research associate (CRA) will know the patient's arm. The rest of the clinical team will be blinded. The self-questionnaires will be completed by the patients and then retrieved by the CRA who will enter the data into the eCRF, with no possible access to this data by the investigators.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast cancer.
- •Indication of breast lumpectomy, oncoplasty or mastectomy.
- •Person over 18 years old
排除标准
- •Person with a history of breast cancer surgery.
- •Person with severely impaired physical and/or psychological health, which, in the opinion of the investigator, may affect the participant's compliance to the study.
- •Individuals who have difficulty understanding the French language orally.
- •Person who does not have Internet access at home or at work.
- •Person placed under court protection.
- •Person who is not a member or beneficiary of a national health insurance system.
- •Person who has not given oral informed consent after a reflection period.
- •Person participating in another research study with an exclusion
研究组 & 干预措施
Arm A: Web platform and video information support
After usual preoperative information delivered by surgeon, patients allocated to Arm will be able to access to video information support and web platform.
干预措施: Consultation of a Web Platform (Other)
Arm B: Standard Preoperative information
Patients randomized in Arm B will only receive usual preoperative information delivered by the surgeon.
结局指标
主要结局
Rate of patients with perioperative anxiety symptoms
时间窗: The morning of surgery (Day 0)
Anxiety is assessed with the Amsterdam Preoperative Anxiety and Information Scale (APAIS) using 3 distinct areas: Anesthesia Anxiety (items 1 and 2), Surgery Anxiety (items 4 and 5), and Need for Information (items 3 and 6).Each question is measured on a 5-point scale ranging from 1 "not at all" to 5 "extremely". To obtain the overall anxiety score, the scores of the 4 anxiety items (1, 2, 4 and 5) are added together. Subjects are considered anxious when they have a score strictly higher than 10 for these 4 items.
次要结局
- Satisfaction of the experimental group(The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks))
- Evolution of anxiety related to the surgery(The pre-operative consultation and the morning of the surgery (Day 0))
- Use of analgesics(15 postoperative days)
- Evaluation of satisfaction and understanding of preoperative medical information(The pre-operative consultation, the morning of the surgery (Day 0), at discharge (between Day 0 and 3) and at the postoperative visit (at 6 weeks))
- Intravenous anesthetic consumption(Day of the surgery (Day 0))
- Number of days of use of anxiolytics(15 postoperative days)
- Number of connections to the EDOP platform for experimental group(The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks))
- Rate of patients who used the Internet and/or contacted the gynecology department(The morning of the surgery (Day 0) and at the postoperative visit (at 6 weeks))