Breast CancerSENEDOPNCT05350527
Impact of Video Information Support on Preoperative Anxiety in Breast Cancer Surgery
A study testing Consultation of a Web Platform in people with Breast Cancer, run by University Hospital, Montpellier at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Consultation of a Web Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Jun 2022to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer.
- Indication of breast lumpectomy, oncoplasty or mastectomy.
- Person over 18 years old
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Béziers
Béziers
Clinique de Clémentville
Montpellier, 34000
CHU de Montpellier
Montpellier, 34295
CHU de Nîmes
Nîmes, 30029
About this study
Official title: Impact of a Personalized and Secure Video Information Support and Web Platform on Preoperative Anxiety in the Context of Breast Cancer Surgery
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.
Read the 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
- Being tested
- Consultation of a Web Platform
- Keywords
- Preoperative Anxiety, Preoperative information, Video support, Web platform, Breast cancer surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation of a Web PlatformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The morning of surgery (Day 0)
Secondary outcomes (8)
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.
Measured: The pre-operative consultation and the morning of the surgery (Day 0)
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).
Measured: 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 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.
Measured: The morning of the surgery (Day 0) and at the postoperative visit (at 6 weeks)
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.
Measured: Day of the surgery (Day 0)
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
Measured: 15 postoperative days
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
Measured: 15 postoperative days
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.
Measured: The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks)
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)
Measured: The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start22 Jun 2022
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Why it stopped: The software used for the collection of the primary endpoint is no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- EDOP Society
- Responsible party
- Sponsor
- Investigators
- Martha DURAES, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350527
- Sponsor's protocol ID
- RECHMPL21_0680
- Acronym
- SENEDOP
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Personalized and Secure Video Information Support and Web Platform on Preoperative Anxiety in the Context of Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05350527
- Acronym / sponsor ID
- SENEDOP / RECHMPL21_0680
- Conditions
- Breast Cancer
- Keywords
- Preoperative Anxiety, Preoperative information, Video support, Web platform, Breast cancer surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The software used for the collection of the primary endpoint is no longer available.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- EDOP Society
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Web platform and video information support | Experimental | Other: Consultation of a Web PlatformAfter usual preoperative information delivered by surgeon, patients allocated to Arm will be able to access to video information support and web platform. |
| Arm B: Standard Preoperative information | No intervention | –Patients randomized in Arm B will only receive usual preoperative information delivered by the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed breast cancer.
- Indication of breast lumpectomy, oncoplasty or mastectomy.
- Person over 18 years old
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultation of a Web PlatformPatients 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. | Other | Arm A: Web platform and video information support |
Primary outcome
Rate of patients with perioperative anxiety symptoms
Time frame: The morning of surgery (Day 0)
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.
8 secondary outcomes
Evolution of anxiety related to the surgery
Time frame: The pre-operative consultation and the morning of the surgery (Day 0)
Evaluation of satisfaction and understanding of preoperative medical information
Time frame: 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
Time frame: The morning of the surgery (Day 0) and at the postoperative visit (at 6 weeks)
Intravenous anesthetic consumption
Time frame: Day of the surgery (Day 0)
Use of analgesics
Time frame: 15 postoperative days
Number of days of use of anxiolytics
Time frame: 15 postoperative days
Number of connections to the EDOP platform for experimental group
Time frame: The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks)
Satisfaction of the experimental group
Time frame: The morning of the surgery (Day 0) and at the post-operative visit (at 6 weeks)
Results and safety
The study was stopped early (reason given: The software used for the collection of the primary endpoint is no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha DURAES, MD study director
University Hospital, Montpellier
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation of a Web Platform in people with Breast Cancer, run by University Hospital, Montpellier at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The software used for the collection of the primary endpoint is no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with perioperative anxiety symptoms (time frame: The morning of surgery (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.