An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients (STARLINGS Study)

Study Overview
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Brief Summary
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To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.

Detailed Description
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The primary objectives of this study are to assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Based on these insights predictive models for the development of moderate to severe fibrosis and moderate to poor cosmetic outcome will be developed. Second, the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms will be assessed.

Official Title
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An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.

Conditions
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Breast Fibrosis, Breast Cancer, Breast Cancer Female, Breast Neoplasms, Breast Carcinoma in Situ, Breast Carcinoma

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged ≥ 18 years History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed. Operated between 1st of January 2016 and 31th of December 2020 Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy (22, 23), with or without boost Adequate understanding of the Dutch language and written informed consent Exclusion Criteria: Any breast surgery or re-irradiation on the breast area after BCT Progression of disease (and additional treatment) since BCT Patients who received partial breast irradiation Current pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STARLINGS study population<br>The study population consists of breast cancer patients who were treated with breast conserving therapy (BCT) at one of the four participating hospitals (Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus hospital Gasthuis and Vlietland), for non-metastatic, histological proven invasive breast cancer or DCIS between 2016 and 2020 (at time of inclusion in 2022 respectively 6 to 2 years after treatment), and subsequently received adjuvant (whole breast) irradiation (WBI), with or without boost, at the Erasmus MC as part of their BCT. | Other: no intervention<br>* At one timepoint patients will get physical examination of the breasts, medical photographs will be taken, and they will fill in five questionnaires about satisfaction of the breasts, quality of life and general health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis of the breast as measured by CTCAE v5 scale | Fibrosis will be graded by the researcher using the CTCAE v5 scale. On the CTCAE scale of superficial soft tissue fibrosis: Grade 0 = no fibrosis, Grade 1 = mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up), Grade 2 = Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL, Grade 3 = Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self care ADL, Grade 4 = Generalized; associated with signs or symptoms of impaired breathing or feeding, Grade 5 = Death. We are planning to score fibrosis of the breast as none/mild (grade 0-1) or moderate/severe (grade 2-3). | 2-6 years after breast conserving treatment. 1 point of measurement. | 
| Cosmetic outcome as measured by 9-item questionnaire | Cosmetic outcome will be evaluated by means of a 9-item cosmetic patient questionnaire filled out by the patient with scoring on a four point scale (range from 'excellent' to 'poor' per item). | 2-6 years after breast conserving treatment. 1 point of measurement. | 
| Cosmetic outcome as measured by BCCT.core software | Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC, the Faculdade de Medicina da Universidade do Porto) cosmetic outcome will be assessed. | 2-6 years after breast conserving treatment. 1 point of measurement. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, as measured by BREAST-Q | Which includes the following domains: psychosocial well being, sexual well being, satisfaction with the breasts, physical well being, adverse effects of radiation. All domains are scored 0 to 100 points, higher points means a better outcome. | 2-6 years after breast conserving treatment. 1 point of measurement. | 
| Quality of life, as measured by EORTC Quality of Life Questionnaires-C30 | Which include functional domains, global health status and symptom scales. For functional domains and global health status, scores range from 0 to 100. Higher scores means a better level of functioning. For symptoms scales, scores range from 0 to 100. Higher scores represent a greater degree of symptoms. | 2-6 years after breast conserving treatment. 1 point of measurement. | 
| Quality of life, as measured by EORTC Quality of Life Questionnaires-B23 | Which include functional domains, global health status and symptom scales. For functional domains and global health status, scores range from 0 to 100. Higher scores means a better level of functioning. For symptoms scales, scores range from 0 to 100. Higher scores represent a greater degree of symptoms. | 2-6 years after breast conserving treatment. 1 point of measurement. | 
| Quality of life, as measured by EQ-5D-5L - five dimensions | The EQ-5D-5L include five questions about five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression. For each dimension, participants choose one of five levels that best fits their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). | 2-6 years after breast conserving treatment. 1 point of measurement. | 
| Quality of life, as measured by EQ-5D-5L - VAS | The EQ-5D-5L include, apart from the five questions about five dimensions (see above), a visual analogue scale (VAS). The VAS provides rating of the participant's health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine'). | 2-6 years after breast conserving treatment. 1 point of measurement. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrosis, Cosmetic outcome, Quality of life, Oncoplastic breast surgery, Radiotherapy