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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

775 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2024-09-20

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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STARLINGS study population

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.

no intervention

Intervention Type OTHER

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.

Interventions

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no intervention

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No