Aspects of Breast-conserving Surgery

Quality of Life Clinical Trial

Official title:

Prospective Study of Cosmetic Outcome and Quality of Life for Women Undergoing Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227613
• Other study ID #: 2018/827
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Cosmetic Outcome
• Quality of Life

Locations

Country	Name	City	State
Sweden	Central Hospital of Kristianstad	Kristianstad	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Breast-Q questionnaire to evaluate quality of life and satisfaction with outcome for the patient.Score 0-100, higher score indicates a better outcome. There is also an additional QoL questionnaire at 1-year follow up (EORTC QLQ-C30 and QLQ-BR23).	Change from baseline (time of diagnosis) to 1-year follow-up
Primary	Cosmetic outcome	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.	Change from baseline (time of diagnosis) to 1-year follow-up