NCT06761196

Brief Summary

The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery. Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
114mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Sep 2025Sep 2035

First Submitted

Initial submission to the registry

December 12, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2035

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

December 12, 2024

Last Update Submit

September 5, 2025

Conditions

Breast Cancer SurgeryQuality of Life

Keywords

breast canceroncoplastic surgeryquality of lifequality of recovery

Outcome Measures

Primary Outcomes (1)

  • Quality of life measured with BREAST-Q

    The BREAST-Q is a rigorously developed patient-reported outcome measure for use in cosmetic and reconstructive breast surgery and clinical practice. The BREAST-Q conceptual framework covers 2 domains: quality of life, and patient satisfaction. There is three independent modules developped for breast cancer (mastectomy, breast-conserving therapy, reconstruction). A conversion table is used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

    From enrollment to the end of 5 years follow-up

Secondary Outcomes (4)

  • Quality of life measured with EORTC QLQ C30

    From enrollment to the end of 5 years follow-up

  • Quality of life measured with EORTC QLQ-BR42

    From enrollment to the end of 5 years follow-up

  • Safety of postoperative period

    Form enrollment to the end of 5 years follow-up

  • Quality of postoperative period

    At enrollment aund day 1 and 7 after surgery

Interventions

QuestionnaireOTHER

The quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Patient aged 18 or over
  • Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
  • Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
  • Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
  • Patient with a computer, tablet or smartphone connected to the Internet.
  • Patient followed in the center on a regular basis according to standard recommendations.

You may not qualify if:

  • Patient requiring surgical intervention under local anesthesia only.
  • Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
  • Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
  • Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
  • Patient under protective measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Civils de Colmar

Colmar, 68024, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Massimo LODI, MD

CONTACT

0033389124171massimo.lodi@ch-colmar.fr

Magali EYRIEY

CONTACT

0033389124810magali.eyriey@ch-colmar.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

January 7, 2025

Study Start

September 2, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2035

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)