Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Histologically confirmed breast cancer
- Scheduled for breast lumpectomy, oncoplasty, or mastectomy
- Female, aged 18 to 75 years
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
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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