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CompletedNCT05449340BEAUTIFY-3Updated Mar 1, 2024

Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life

An interventional study of BEAUTIFY application in Breast Cancer, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

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.

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Conditions studied

  • Breast Cancer

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Keywords

  • mastectomy
  • quality of life
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    BEAUTIFY application

    Device: BEAUTIFY application

Interventions

  • DeviceBEAUTIFY application

    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.

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What researchers measure

Primary outcomes

  1. Patient compliance with the program

    Yes/No: study will be considered feasible if at least 80% of patients complete the program

    Time frame: End of study (12 months)

  2. Patient satisfaction with the intervention

    Yes/No: study will be considered feasible if at least 80% of patients are satisfied.

    Time frame: End of study (12 months)

Secondary outcomes

  1. Compliance with completing the BEAUTIFY application

    % of weeks where information is recorded out of the total number of weeks

    Time frame: End of study (12 months)

  2. 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

    Time frame: Baseline

  3. Patient quality of life following surgery

    EORTC QLQ C30: score of 1-7 for each item

    Time frame: 1 month

  4. Patient quality of life following surgery

    EORTC QLQ C30: score of 1-7 for each item

    Time frame: 3 months

  5. Patient quality of life following surgery

    EORTC QLQ C30: score of 1-7 for each item

    Time frame: 6 months

  6. Satisfaction of patients with their care

    EORTC PATSAT-C33: score 0-100

    Time frame: 1 month

  7. Satisfaction of patients with their care

    EORTC PATSAT-C33: score 0-100

    Time frame: 3 months

  8. Satisfaction of patients with their care

    EORTC PATSAT-C33: score 0-100

    Time frame: 6 months

  9. Rate of post-operative complications

    % patients with a complication noted in medical file

    Time frame: 6 months

  10. Type of post-operative complications

    List of the complications affected patients as noted in medical file

    Time frame: 6 months

  11. Readmission rate for surgical or medical reason

    % patients readmitted

    Time frame: 6 months

  12. Return to work and/or social activities

    Date: Patients contacted by email or telephone

    Time frame: 1 year

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Study locations

1 site
  • CHU de Nîmes
    Nîmes, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05449340
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jul 8, 2022
Start date
Jul 25, 2022
Primary completion
Feb 16, 2024
Completion
Feb 16, 2024
Last update
Mar 1, 2024

Study contacts

Frédéric Fiteni
principal investigator · CHU de Nimes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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