Aspects of Breast-conserving Surgery
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|ClinicalTrials.gov Identifier: NCT04227613|
Recruitment Status : Enrolling by invitation
First Posted : January 13, 2020
Last Update Posted : January 18, 2020
|Condition or disease|
|Breast Neoplasm Cosmetic Outcome Quality of Life|
This is a clinical study with the aim to investigate how breast cancer patient's quality of life changes after breast cancer surgery, as well as looking at the cosmetic outcomes for the same patient group. The study is conducted prospectively, with patients being included forward in time when they are diagnosed with breast cancer in Kristianstad hospital, Sweden. The study started in January 2019 and is expected to continue enrollment for two years, with the aim of recruiting 300 patients. The patients fill out a quality of life questionnaire (Breast-Q) at baseline, which is defined as time of diagnosis, and second Breast-Q questionnaire 1-year post surgery. Photos are also taken of the breasts both preoperatively and postoperatively and the photos are assessed by a computer program validated to assess cosmetic outcomes after breast cancer surgery, called BCCT.core, and secondly the cosmetic results of the breasts are evaluated by the surgeon and patient herself on a 10-grade scale. In addition study specific items covering for example psychiatric comorbidity, BMI and smoking are retrieved.
The study hypothesis is that patients undergoing breast cancer surgery overall have a good quality of life 1-year after their diagnosis, especially if they are treated with a surgical approach that takes into account both the best oncological treatment as well as the best surgical technique for cosmetic outcome, so called oncoplastic surgery. The other hypothesis is that cosmetic results will be overall favorable for the group of patients who are operated with breast-conserving techniques, and most favorable in those patients who have undergone oncoplastic surgery. Secondly the study aims to see if there are other patient related variables that affect the quality of life or cosmetic outcome, for example cytostatic treatment, a high body mass index, smoking or psychiatric history prior to diagnosis.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Prospective Study of Cosmetic Outcome and Quality of Life for Women Undergoing Breast Cancer Surgery|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
- Quality of life [ Time Frame: Change from baseline (time of diagnosis) to 1-year follow-up ]Breast-Q questionnaire to evaluate quality of life and satisfaction with outcome for the patient.Score 0-100, higher score indicates a better outcome.
- Cosmetic outcome [ Time Frame: Change from baseline (time of diagnosis) to 1-year follow-up ]
BCCT.core (breast cancer conservation treatment. cosmetic results) program, together with both surgeon's and patient's score to evaluate cosmetic outcome.
BCCT.core scores from 1 to 4. 4 is the worse cosmetic outcome. Patients and surgeon will score from 1-10. Higher score indicates a better cosmetic outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227613
|Central Hospital of Kristianstad|
|Kristianstad, Skåne, Sweden, 29133|
|Principal Investigator:||Tor Svensjö, PhD||Region Skane|
|Principal Investigator:||Kim Gulis, MD||Region Skåne / Lund University|