Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID05350527

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

Led by University Hospital, Montpellier · Updated on 2025-01-22

200

Participants Needed

4

Research Sites

197 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Montpellier

Lead Sponsor

E

EDOP Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial investigates the impact of personalized medical information delivered through a secure internet platform on preoperative anxiety in women undergoing breast cancer surgery. Breast cancer patients often experience high anxiety before surgery, which can affect anesthesia use and postoperative pain management. Visual tools like videos may help reduce anxiety, especially for patients with varying levels of education or language skills. This study evaluates whether unlimited access to this video-based platform can lower anxiety levels before surgery. Participants in the experimental group will receive standard oral and written preoperative information plus access to the EDOP internet platform. This secure platform includes an explanatory video about breast surgery and practical information on the surgery and recovery, accessible at any time during follow-up. The study is a multicenter, prospective, randomized, single-blind trial, with nursing staff blinded to group assignments. During the study, patients will complete self-questionnaires on anxiety, satisfaction, and understanding before surgery, the morning of surgery, at discharge, and six weeks postoperatively. Researchers will measure anxiety levels on the morning of surgery as the primary outcome. Secondary outcomes include changes in anxiety, medication use after surgery, and patient interactions with other medical resources. The study also monitors platform usage and satisfaction in the experimental group. Participation requires a follow-up lasting at least six weeks after surgery.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed breast cancer
  • Scheduled for breast lumpectomy, oncoplasty, or mastectomy
  • Female, aged 18 to 75 years
Not Eligible

You will not qualify if you...

  • History of breast cancer surgery
  • Severely impaired physical or psychological health affecting study compliance
  • Difficulty understanding spoken French
  • No Internet access at home or work
  • Under legal protection or court supervision
  • Not covered by a national health insurance system
  • Has not given oral informed consent after reflection
  • Participating in another research study with exclusion criteria

AI-Screening

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Trial Site Locations

Total: 4 locations

1

CH Béziers

Béziers, France

Actively Recruiting

2

Clinique de Clémentville

Montpellier, France, 34000

Not Yet Recruiting

3

CHU de Montpellier

Montpellier, France, 34295

Actively Recruiting

4

CHU de Nîmes

Nîmes, France, 30029

Actively Recruiting

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Research Team

M

Martha DURAES, MD

G

Gauthier RATHAT, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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