Impact of Video Information Support on Preoperative Anxiety in Breast Cancer Surgery

Breast Cancer Clinical Trial

— SENEDOP  

Official title:

Impact of a Personalized and Secure Video Information Support and Web Platform on Preoperative Anxiety in the Context of Breast Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350527
• Other study ID #: RECHMPL21_0680
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Martha DURAES, MD
• Phone: +336 31 32 91 58
• Email: m-duraes[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• the change in anxiety between the preoperative visit and the morning of the procedure,

• patient satisfaction and understanding of the preoperative medical information received after the preoperative visit, on the morning of the operation, at discharge (between D0 and D3) and at the postoperative visit (6 weeks),

• consultation of other websites and contact with the medical team, on the morning of the operation and at the post-operative visit (6 weeks),

• the quantity of anaesthetic products used during the operation

• the consumption of analgesics during the 15 days after the operation

• consumption of anxiolytics during the 15 postoperative days

For the experimental group:

• To evaluate the use of the EDOP platform,

• To evaluate patient satisfaction with this platform.

This is a Multicenter, prospective, randomized, single-blind study. Only the clinical study technician (CST) will know the patient's group. Nursing staff will be blinded. Self-questionnaires will be filled out by the patients and then retrieved by the CT who will enter the data into the eCRF, with no access to these data by the investigators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed breast cancer.

• Indication of breast lumpectomy, oncoplasty or mastectomy.

• Person over 18 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Consultation of a Web Platform
Patients willing to participate in this research and randomized in the experimental arm will benefit, in addition to standard preoperative medical information, an access to the EDOP internet platform via personalized and secure access codes. They will be able to watch an explanatory video about breast surgery and find all the essential, practical and useful information about their intervention and the postoperative effects for the duration of their follow-up.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	EDOP Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with perioperative anxiety symptoms	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.	The morning of surgery (Day 0)
Secondary	Evolution of anxiety related to the surgery	The evolution of anxiety related to the surgery is evaluated by the variation on score of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) between the preoperative consultation and the morning of the intervention.; The 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.	The pre-operative consultation and the morning of the surgery (Day 0)
Secondary	Evaluation of satisfaction and understanding of preoperative medical information	This outcome is evaluated by the Medical Information Comprehension and Satisfaction Assessment Questionnaire was designed to assess 3 items: quality of medical information, comprehension of different topics, and overall satisfaction with medical information.; To calculate the score: items are rated from 1 (Not at all) to 5 (Totally) for questions 1 and 3; items are rated from 5 (Not at all) to 1 (Totally) for question 2; Visual Analogue Scale: 1 point for a score of 0 to 20, 2 points for a score of 21 to 40, 3 points for a score of 41 to 60, 4 points for a score of 61 to 80, 5 points for a score of 81 to 100 (question 4).	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)
Secondary	Rate of patients who used the Internet and/or contacted the gynecology department	The Questionnaire evaluating Internet use and contact with the gynecology department was designed to assess the use of the Internet and contact with the clinical team to obtain additional information about the procedure. It also assesses the reasons for using or not using the Internet, as well as the reliability of the information consulted on the Internet.; The patient must specify whether she consults the Internet in a general way for her health (item 1) and she must indicate whether or not she has used the internet since the last visit to obtain additional information about her procedure (item 2), she must give: If yes, the reasons for using the Internet (items 3, 4 and 5); If no, the reasons for not using the Internet (items 6) The patient must mention whether she contacted the gynecology department by phone and/or email (item 7) and whether she consulted urgently for her breast surgery (item 8), in order to obtain additional information about the procedure.	The morning of the surgery (Day 0) and at the postoperative visit (at 6 weeks)
Secondary	Intravenous anesthetic consumption	The consumption of intravenous anesthetic is mesured by the hypnotics in milligrams and morphine in micrograms. This data will be collected from the patient's computerized medical record.	Day of the surgery (Day 0)
Secondary	Use of analgesics	Use of analgesics is classified in 3 categories: levels 1, 2 and 3. A calendar will be given to patients so that they can record their use of analgesics during the 15 days postoperatively. This calendar will be retrieved at the 6-week postoperative visit	15 postoperative days
Secondary	Number of days of use of anxiolytics	A calendar will be given to patients so that they can record their use of anxiolytics during the 15 days postoperatively. This calendar will be retrieved at the 6-week postoperative visit	15 postoperative days
Secondary	Number of connections to the EDOP platform for experimental group	The number of connections to the EDOP platform is assessed for patients in the experimental group (Arm A), using question 1 of the questionnaire evaluating the number of connections and patient satisfaction with the EDOP platform.	The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks)
Secondary	Satisfaction of the experimental group	The satisfaction of the patients in the experimental group is assessed using the questionnaire evaluating the number of connections and the satisfaction of the patients concerning the EDOP platform (Questions 3, 7 and 8)	The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks)