Aspects of Breast-conserving Surgery

NCT ID: NCT04227613

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 351 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-06-30

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.

Conditions

Breast Neoplasm; Cosmetic Outcome; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Rydén, Prof

Role: PRINCIPAL_INVESTIGATOR

Lund University

Tor Svensjö, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne

Kim Gulis, MD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne / Lund University

Locations

Central Hospital of Kristianstad

Kristianstad, Skåne County, Sweden

Countries

Sweden

References

Gulis K, Ellbrant J, Bendahl PO, Svensjo T, Ryden L. Health-related quality of life by type of breast surgery in women with primary breast cancer: prospective longitudinal cohort study. BJS Open. 2024 May 8;8(3):zrae042. doi: 10.1093/bjsopen/zrae042.

Reference Type: DERIVED

PMID: 38829692 (View on PubMed)

Other Identifiers

2018/827

Identifier Type: -

Identifier Source: org_study_id