Clinical trial · Observational
Quality of Life After Breast Cancer Surgery
Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study
NCT06761196CI-TRIAL-00094668SOCOM-QoLrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quality of life measured with BREAST-Q
- timeFrame
- From enrollment to the end of 5 years follow-up
- description
- 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.
Secondary outcomes (4)
- measure
- Quality of life measured with EORTC QLQ C30
- timeFrame
- From enrollment to the end of 5 years follow-up
- description
- The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.