No intervention
OtherAt 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.
NCT Number: NCT05263362
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.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Albert Schweitzer hospital, Dordrecht, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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).
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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).
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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.
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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.
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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.
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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.
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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).
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
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').
Erasmus Medical Center
Other
An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.
Acronym: STARLINGS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05700396
Breast Cancer, Breast Cancer Female
Boston, Massachusetts, United States
View Trial DetailsNCT04245657
Arthralgia, Breast Cancer
Izmir, Çiğli, Turkey (Türkiye)
View Trial DetailsNCT06115486
Behavior, Breast Cancer
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06062992
Breast Cancer, Breast Cancer Female
Sittard, Limburg, Netherlands
View Trial Details