Breast Cancer
Conditions
Keywords
Breast cancer, Mastectomy, Radiotherapy, Reconstruction, Quality of life, Patient Reported Outcomes
Brief summary
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.
Interventions
None listed
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastro Clinic, The Netherlands
Janine M. Simons MD PhD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction at 1 year | From enrollment to one year follow-up after treatment. | 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. |
| Patient quality of life at 1 year | From enrollment to one year follow-up after treatment. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications prior to and following radiotherapy | From enrollment to end of study follow-up (i.e. 5 years after treatment). | 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 |
| Cost-effectiveness and consumption of medical care and materials. | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). | 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. |
| Patient satisfaction at 3 and 5 years | From enrollment to 3 and 5 years follow-up after treatment. | 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. |
| Breast cancer recurrence rates at 3, and 5 years | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). | 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. |
| Recurrence free interval, disease free survival and overall survival at 3 and 5 years. | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). | 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 to adjuvant treatment (radiotherapy/systemic therapy). | Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable). | To assess time to adjuvant oncologic treatment (radiotherapy/systemic therapy) |
| Patient quality of life at 3 and 5 years | From enrollment to 3 and 5 years follow-up after treatment. | 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). |
Countries
Netherlands
Contacts
Primary ContactJanine M Simons, MD PhD
Outcome results
None listed