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

NCT ID: NCT05350527

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2026-04-01

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Consultation of a Web Platform

Intervention Type: OTHER

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.

Arm B: Standard Preoperative information

Patients randomized in Arm B will only receive usual preoperative information delivered by the surgeon.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EDOP Society

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha DURAES, MD

Role: STUDY_DIRECTOR

Montpellier University Hospital

Locations

CH Béziers

Béziers, , France

Site Status: RECRUITING

Clinique de Clémentville

Montpellier, , France

Site Status: NOT_YET_RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status: RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Martha DURAES, MD

Role: CONTACT

m-duraes@chu-montpellier.fr

+336 31 32 91 58

Gauthier RATHAT, MD

Role: CONTACT

g-rathat@chu-montpellier.fr

Facility Contacts

Lidia LASCH, MD

Role: primary

Pierre Bertrand, MD

Role: primary

Martha DURAES, MD

Role: primary

m-duraes@chu-montpellier.fr

Catherine MARSOLLIER FERRER, MD

Role: primary

catherine.ferrer@chu-nimes.fr

Mahutondji Calèbe SOMASSE, CRA

Role: backup

mahutondji.somasse@chu-nimes.fr

+334 66 68 36 84

Other Identifiers

RECHMPL21_0680

Identifier Type: -

Identifier Source: org_study_id