Breast NeoplasmNCT04227613
Aspects of Breast-conserving Surgery
An observational study of Breast Neoplasm and Cosmetic Outcome, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Cosmetic Outcome, Quality of Life
- How many people
- 351 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women who are diagnosed with breast cancer in Central Hospital of Kristianstad
Who may be able to join
- Women with breast cancer diagnosed in Central Hospital of Kristianstad from 1/1 2019
Who cannot join
- Patients who lack the ability to read and write Swedish
- Patients that are not able to understand the information given
- Palliative care patients
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Central Hospital of Kristianstad
Kristianstad, Skåne County, 29133
About this study
Official title: Prospective Study of Cosmetic Outcome and Quality of Life for Women Undergoing Breast Cancer Surgery
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.
Read the 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
- Keywords
- Humans, prospective studies, breast neoplasms, breast, patient satisfaction, patient reported outcome measures, oncoplastic breast surgery, follow-up studies, mastectomy, quality of life, Sweden
- Medical subject headings
- Breast Neoplasms, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from baseline (time of diagnosis) to 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Sponsor
- Investigators
- Lisa Rydén, Prof, Principal investigator, Lund UniversityTor Svensjö, PhD, Principal investigator, Region SkaneKim Gulis, MD, Principal investigator, Region Skåne / Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227613
- Sponsor's protocol ID
- 2018/827
- Status last verified
- Nov 2022
- First submitted
- 9 Jan 2020
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38829692
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Cosmetic Outcome and Quality of Life for Women Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04227613
- Acronym / sponsor ID
- 2018/827
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women who are diagnosed with breast cancer in Central Hospital of Kristianstad
Key inclusion criteria (1 listed)
- Women with breast cancer diagnosed in Central Hospital of Kristianstad from 1/1 2019
Key exclusion criteria (3 listed)
- Patients who lack the ability to read and write Swedish
- Patients that are not able to understand the information given
- Palliative care patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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. There is also an additional QoL questionnaire at 1-year follow up (EORTC QLQ-C30 and QLQ-BR23).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 38829692Gulis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Rydén, Prof principal investigator
Lund University
Tor Svensjö, PhD principal investigator
Region Skane
Kim Gulis, MD principal investigator
Region Skåne / Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm and Cosmetic Outcome, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Change from baseline (time of diagnosis) to 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04227613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.