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Completed

NCT Number: NCT05449340

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

BEAUTIFY application

Device

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Compliance with completing the BEAUTIFY application

    Time frame: End of study (12 months)

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

  2. Patient quality of life following surgery

    Time frame: Baseline

    European Organisation For Research And Treatment Of Cancer Quality of Life of Cancer Patients (EORTC QLQ C30): score of 1-7 for each item

  3. Patient quality of life following surgery

    Time frame: 1 month

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

  4. Patient quality of life following surgery

    Time frame: 3 months

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

  5. Patient quality of life following surgery

    Time frame: 6 months

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

  6. Satisfaction of patients with their care

    Time frame: 1 month

    EORTC PATSAT-C33: score 0-100

  7. Satisfaction of patients with their care

    Time frame: 3 months

    EORTC PATSAT-C33: score 0-100

  8. Satisfaction of patients with their care

    Time frame: 6 months

    EORTC PATSAT-C33: score 0-100

  9. Rate of post-operative complications

    Time frame: 6 months

    % patients with a complication noted in medical file

  10. Type of post-operative complications

    Time frame: 6 months

    List of the complications affected patients as noted in medical file

  11. Readmission rate for surgical or medical reason

    Time frame: 6 months

    % patients readmitted

  12. Return to work and/or social activities

    Time frame: 1 year

    Date: Patients contacted by email or telephone

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: BEAUTIFY-3

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2022
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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