Breast Reconstruction and Radiotherapy

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.

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).