Clinical trial · Observational
Breast Reconstruction and Radiotherapy
Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization
- 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)
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of radiotherapy.
Conditions
Conditions (1)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- All patients, 18 years or older, treated with mastectomy and radiotherapy for breast cancer.
- description
- Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included. The following treatments of interest will be identified: * "immediate breast reconstruction" (implant-based or autologous) * "delayed breast reconstruction" group (implant-based or autologous) * "no breast reconstruction" group
Primary outcomes (2)
- measure
- Patient satisfaction at 1 year
- timeFrame
- From enrollment to one year follow-up after treatment.
- description
- The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire BREAST-Q. With the BREAST-Q questionnaire, four domains will be evaluated (psychosocial well-being (score ranges from 10 to 50), physical well-being (score ranges from 10 to 30), sexual well-being (score ranges from 6 to 30) and satisfaction with breasts (score ranges from 4 to 16) and higher scores indicate better outcomes.
- measure
- Patient quality of life at 1 year
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Diagnosed with unilateral non-metastatic breast cancer * (to be) Treated with mastectomy and to be treated with adjuvant radiotherapy * Willing and able to provide written informed consent Exclusion Criteria: * History of DCIS or invasive breast cancer * Previous thoracic radiotherapy treatment * History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)
References
Publications (0)
Data not yet available