NCT04227613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

January 9, 2020

Last Update Submit

November 18, 2022

Conditions

Breast NeoplasmCosmetic OutcomeQuality of Life

Keywords

Humansprospective studiesbreast neoplasmsbreastpatient satisfactionpatient reported outcome measuresoncoplastic breast surgeryfollow-up studiesmastectomyquality of lifeSweden

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women who are diagnosed with breast cancer in Central Hospital of Kristianstad

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital of Kristianstad

Kristianstad, Skåne County, 29133, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 38829692DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lisa Rydén, Prof

    Lund University

    PRINCIPAL INVESTIGATOR

  • Tor Svensjö, PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

  • Kim Gulis, MD

    Region Skåne / Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)