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

NCT05350527 | Recruiting

• 1 other identifier: RECHMPL21_0680
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

Preoperative Anxiety; Preoperative information; Video support; Web platform; Breast cancer surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Evolution of anxiety related to the surgery

  The pre-operative consultation and the morning of the surgery (Day 0)

• 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)

• 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)

• Intravenous anesthetic consumption

  Day of the surgery (Day 0)

• Use of analgesics

  15 postoperative days

Study Arms (2)

Arm A: Web platform and video information support

EXPERIMENTAL

After usual preoperative information delivered by surgeon, patients allocated to Arm will be able to access to video information support and web platform.

Other: Consultation of a Web Platform

Arm B: Standard Preoperative information

NO INTERVENTION

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

Interventions

Consultation of a Web Platform 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 A: Web platform and video information support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed breast cancer.
• Indication of breast lumpectomy, oncoplasty or mastectomy.
• Person over 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• EDOP Society: collaborator

Study Sites (4)

CH Béziers

Béziers, France

RECRUITING

Clinique de Clémentville

Montpellier, 34000, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martha DURAES, MD

  Montpellier University Hospital

  STUDY DIRECTOR

Central Study Contacts

Martha DURAES, MD

CONTACT

+336 31 32 91 58; m-duraes@chu-montpellier.fr

Gauthier RATHAT, MD

CONTACT

g-rathat@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 28, 2022
• Study Start: June 22, 2022
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)