Breast CancerBEAUTIFY-3NCT05449340
Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life
A study testing BEAUTIFY application in people with Breast Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BEAUTIFY application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2022to 16 Feb 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patient scheduled for surgery
- Patient able to use a connected electronic object and having a tablet or a smartphone with internet access at home.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
Trial locations and contacts
1 site in 1 country.
About this study
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.
The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "BEAUTIFY" care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.
- Conditions
- Breast Cancer
- Being tested
- BEAUTIFY application
- Keywords
- mastectomy, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEAUTIFY applicationDevice
Interview with the coordinating nurse in the postoperative period to install the BEAUTIFY application on the patient's smartphone and to train her to record any Patients will monitor their symptoms weekly. In case of toxicity grade > 2, the nurse will contact the patient for further information.
| Study group | Role | What they receive |
|---|---|---|
| BEAUTIFY application | Experimental | Not described Receives: Device: BEAUTIFY application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance with the program
Yes/No: study will be considered feasible if at least 80% of patients complete the program
Measured: End of study (12 months)
Patient satisfaction with the intervention
Yes/No: study will be considered feasible if at least 80% of patients are satisfied.
Measured: End of study (12 months)
Secondary outcomes (12)
Compliance with completing the BEAUTIFY application
% of weeks where information is recorded out of the total number of weeks
Measured: End of study (12 months)
Patient quality of life following surgery
European Organisation For Research And Treatment Of Cancer Quality of Life of Cancer Patients (EORTC QLQ C30): score of 1-7 for each item
Measured: Baseline
Patient quality of life following surgery
EORTC QLQ C30: score of 1-7 for each item
Measured: 1 month
Patient quality of life following surgery
EORTC QLQ C30: score of 1-7 for each item
Measured: 3 months
Patient quality of life following surgery
EORTC QLQ C30: score of 1-7 for each item
Measured: 6 months
Satisfaction of patients with their care
EORTC PATSAT-C33: score 0-100
Measured: 1 month
Satisfaction of patients with their care
EORTC PATSAT-C33: score 0-100
Measured: 3 months
Satisfaction of patients with their care
EORTC PATSAT-C33: score 0-100
Measured: 6 months
Rate of post-operative complications
% patients with a complication noted in medical file
Measured: 6 months
Type of post-operative complications
List of the complications affected patients as noted in medical file
Measured: 6 months
Readmission rate for surgical or medical reason
% patients readmitted
Measured: 6 months
Return to work and/or social activities
Date: Patients contacted by email or telephone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start25 Jul 2022
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Fiteni, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449340
- Sponsor's protocol ID
- Prix Ruban Rose/2020/FF-03
- Acronym
- BEAUTIFY-3
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life
- ClinicalTrials.gov ID
- NCT05449340
- Acronym / sponsor ID
- BEAUTIFY-3 / Prix Ruban Rose/2020/FF-03
- Conditions
- Breast Cancer
- Keywords
- mastectomy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 8 Jul 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.
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.
The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "BEAUTIFY" care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEAUTIFY application | Experimental | Device: BEAUTIFY application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer patient scheduled for surgery
- Patient able to use a connected electronic object and having a tablet or a smartphone with internet access at home.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (4 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
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 |
|---|---|---|
| BEAUTIFY applicationInterview with the coordinating nurse in the postoperative period to install the BEAUTIFY application on the patient's smartphone and to train her to record any Patients will monitor their symptoms weekly. In case of toxicity grade > 2, the nurse will contact the patient for further information. | Device | BEAUTIFY application |
Primary outcome
Patient compliance with the program
Time frame: End of study (12 months)
Yes/No: study will be considered feasible if at least 80% of patients complete the program
Patient satisfaction with the intervention
Time frame: End of study (12 months)
Yes/No: study will be considered feasible if at least 80% of patients are satisfied.
12 secondary outcomes
Compliance with completing the BEAUTIFY application
Time frame: End of study (12 months)
Patient quality of life following surgery
Time frame: Baseline
Patient quality of life following surgery
Time frame: 1 month
Patient quality of life following surgery
Time frame: 3 months
Patient quality of life following surgery
Time frame: 6 months
Satisfaction of patients with their care
Time frame: 1 month
Satisfaction of patients with their care
Time frame: 3 months
Satisfaction of patients with their care
Time frame: 6 months
Rate of post-operative complications
Time frame: 6 months
Type of post-operative complications
Time frame: 6 months
Readmission rate for surgical or medical reason
Time frame: 6 months
Return to work and/or social activities
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
Frédéric Fiteni principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEAUTIFY application in people with Breast Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient compliance with the program (time frame: End of study (12 months)). The study lists 2 primary outcomes in all. 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 1 Mar 2024.