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| ID | Type | Description | Link |
|---|---|---|---|
| 10390032310055 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Maastro Clinic, The Netherlands | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients, 18 years or older, treated with mastectomy and radiotherapy for breast cancer. | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction at 1 year | 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. | From enrollment to one year follow-up after treatment. |
| Patient quality of life at 1 year | The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire EQ-5D-5L. The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life). | From enrollment to one year follow-up after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction at 3 and 5 years | To assess patient reported outcomes at 3, and 5 years (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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janine M Simons, MD PhD | Contact | 0031107040521 | j.simons@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | Netherlands |
Other scientist can contact the PI and request data. The purpose of the request should be provided in writing. If a data transfer is agreed upon, the data will be shared according to the Erasmus MC guidelines on data security and after a DTA has been signed by both parties.
Data will be shared and reused only if and dependent on whether access to the data is approved by the Sponsor and PI of the study.
The purpose of the request should be provided in writing. If a data transfer is agreed upon, the data will be shared according to the Erasmus MC guidelines on data security and after a DTA has been signed by both parties.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| From enrollment to 3 and 5 years follow-up after treatment. |
| Patient quality of life at 3 and 5 years | To assess patient reported outcomes at 3, and 5 years (after mastectomy), by means of the validated questionnaire EQ-5D-5L. The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life). | From enrollment to 3 and 5 years follow-up after treatment. |
| Complications prior to and following radiotherapy | To assess complication rates prior to and after radiotherapy (e.g., total number of surgical reinterventions, reconstruction failure, capsular contracture, fibrosis, pain). Data on type of complications and complication rates (categorized as early (<90 days after surgery) or late (>90 days after surgery will be collected | From enrollment to end of study follow-up (i.e. 5 years after treatment). |
| Cost-effectiveness and consumption of medical care and materials. | The main outcomes of the economic evaluation will be the incremental cost-effectiveness per life-year gained and per quality-adjusted life-year gained. Primary care resource use (e.g., visits to the general practitioner, physiotherapist and home care) will be collected using the iMTA Medical Consumption Questionnaire (iMCQ), Productivity Cost Questionnaire (iPCQ) and Valuation of Informal Care Questionnaire (iVICQ) and administered at baseline (after surgery and before radiotherapy) and 3 months after surgery. Secondary care resource use (e.g., inpatient days, outpatient visits, RT and surgery procedures) will be obtained through DHD. | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). |
| Time to adjuvant treatment (radiotherapy/systemic therapy). | To assess time to adjuvant oncologic treatment (radiotherapy/systemic therapy) | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). |
| Breast cancer recurrence rates at 3, and 5 years | Regarding breast cancer recurrence and time-to-event analysis, any (invasive or in situ) local, regional or distant recurrence will be registered as a recurrence event. The locoregional recurrence rate is defined as the time from diagnosis to a local and/or regional recurrence. The distant recurrence rate is defined as the time from diagnosis to a distant recurrence. | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). |
| Recurrence free interval, disease free survival and overall survival at 3 and 5 years. | The recurrence-free interval is defined as the time from diagnosis to any event related to breast cancer, including death from breast cancer. Disease free survival is defined as the time from diagnosis to any event related to breast cancer or death (irrespective of cause of death). Overall survival is defined as the time from diagnosis to death from any cause. Patients will be censored if lost to follow-up before 5 years of follow-up or if they are alive at 5 years follow-up. | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). |
| D017437 |
| Skin and Connective Tissue Diseases |