Clinical trial NCT04227613: Aspects of Breast-conserving Surgery
Official title: Prospective Study of Cosmetic Outcome and Quality of Life for Women Undergoing Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm
Cosmetic Outcome
Quality of Life
Keywords: Humans
prospective studies
breast neoplasms
breast
patient satisfaction
patient reported outcome measures
oncoplastic breast surgery
follow-up studies
mastectomy
quality of life
Sweden
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2020-01-13
Enrollment: 351
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who are diagnosed with breast cancer in Central Hospital of Kristianstad

Brief summary: Prospective study of cosmetic outcome and quality of life for women undergoing breast cancer surgery using patient a reported outcome measure (BREAST-Q) and a computer program validated to assess cosmetic outcomes after breast cancer surgery (BCCT.core) at baseline and on 1-year follow-up.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women with breast cancer diagnosed in Central Hospital of Kristianstad from 1/1 2019

Exclusion Criteria:

* Patients who lack the ability to read and write Swedish
* Patients that are not able to understand the information given
* Palliative care patients

Primary outcomes:
measure: Quality of life
timeFrame: Change from baseline (time of diagnosis) to 1-year follow-up
measure: Cosmetic outcome
timeFrame: Change from baseline (time of diagnosis) to 1-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: Central Hospital of Kristianstad
state: Skåne
Study officials:
affiliation: Lund University
name: Lisa Rydén, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Skåne
name: Tor Svensjö, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Skåne / Lund University
name: Kim Gulis, MD
role: PRINCIPAL_INVESTIGATOR
References: