Breast CancerEORTCQLQBR45NCT04018235
Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer
An observational study of Breast Cancer and Quality of Life, run by Helios University Hospital Wuppertal at 1 site in Germany.
Trial summary
Females breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Quality of Life
- How many people
- 576 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jun 2019to 17 Dec 2021
- 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: The study sample will be composed of a series of consecutive cancer patients who meet the study eligibility criteria in each participating centre
Who may be able to join
- histologically confirmed diagnosis of breast cancer
- no previous primary or recurrent tumour
- ability to understand the language of the questionnaire
- mental fitness to complete a questionnaire
- 18 years of age or above
- written informed consent.
Who cannot join
- no histologically confirmed diagnosis of breast cancer
- previous primary or recurrent tumour
- not mentally fit to complete a questionnaire
- not able to understand the language of the questionnaire
- younger than 18
- refusal of informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
Wuppertal, 42283
About this study
Official title: An International Phase 4 Field Study to Analyse the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer (EORTC QLQ-BR23 Update- EORTCQLQ BR45)
Females breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC QLG decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.
The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer. Participants will be enrolled in three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). Various combinations of therapies are permissible, resulting in a total of 17 subgroups.
- Conditions
- Breast Cancer, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| localized disease or locally advanced disease | Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy | |
| metastatic disease | Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery | |
| follow up disease | Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric Properties of the EORTC QLQ-BR45
Psychometric Properties of the EORTC QLQ-BR45 (scale structure, reliability, internal consistency, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer)
Measured: baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start14 Jun 2019
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Cross-sectional
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios University Hospital Wuppertal
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, Université Catholique de Louvain, Hospital de Câncer de Barretos, University Hospital Rijeka, Evangelische Kliniken Gelsenkirchen, University Medical Center Freiburg, University Hospital Regensburg, Sheba Medical Center, Instituto Nazionale Tumori Fondazione Pascale, Istituto Oncologico Veneto IRCCS, Oslo University Hospital, Jagiellonian University, Oncology Department Hospital of Navarre, University of Leeds, The Netherlands Cancer Institute, Tumor- und Brust-zentrum ZeTuP St. Gallen, National Taiwan University, Taipei Veterans General Hospital, Taiwan, National Center for Global Health and Medicine, Japan, King Hussein Cancer Center, Maria Sklodowska-Curie National Research Institute of Oncology, Kansai Medical University, Tikur Anbessa Hospital, Tata Memorial Hospital, Mekelle University
- Responsible party
- Sponsor
- Investigators
- Vesna Bjelic-Radisic, Principal investigator, Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018235
- Sponsor's protocol ID
- EORTC QLQ BR45
- Acronym
- EORTCQLQBR45
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.
PubMed 8874337Bjelic-Radisic V, Cardoso F, Cameron D, Brain E, Kuljanic K, da Costa RA, Conroy T, Inwald EC, Serpentini S, Pinto M, Weis J, Morag O, Lindviksmoen Astrup G, Tomaszweksi KA, Pogoda K, Sinai P, Sprangers M, Aaronson N, Velikova G, Greimel E, Arraras J, Bottomley A; EORTC Quality of Life Group and Breast Cancer Group. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Ann Oncol. 2020 Feb;31(2):283-288. doi: 10.1016/j.annonc.2019.10.027. Epub 2019 Dec 18.
PubMed 31959345
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Phase 4 Field Study to Analyse the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer (EORTC QLQ-BR23 Update- EORTCQLQ BR45)
- ClinicalTrials.gov ID
- NCT04018235
- Acronym / sponsor ID
- EORTCQLQBR45 / EORTC QLQ BR45
- Conditions
- Breast Cancer, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Helios University Hospital WuppertalUniversity, hospital or other
- Collaborators
- Medical University of Graz, Université Catholique de Louvain, Hospital de Câncer de Barretos, University Hospital Rijeka, Evangelische Kliniken Gelsenkirchen, University Medical Center Freiburg, University Hospital Regensburg, Sheba Medical Center, Instituto Nazionale Tumori Fondazione Pascale, Istituto Oncologico Veneto IRCCS, Oslo University Hospital, Jagiellonian University, Oncology Department Hospital of Navarre, University of Leeds, The Netherlands Cancer Institute, Tumor- und Brust-zentrum ZeTuP St. Gallen, National Taiwan University, Taipei Veterans General Hospital, Taiwan, National Center for Global Health and Medicine, Japan, King Hussein Cancer Center, Maria Sklodowska-Curie National Research Institute of Oncology, Kansai Medical University, Tikur Anbessa Hospital, Tata Memorial Hospital, Mekelle University
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 12 Jul 2019 (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.
Females breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC QLG decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.
The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer. Participants will be enrolled in three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). Various combinations of therapies are permissible, resulting in a total of 17 subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| localized disease or locally advanced disease | – | –Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy |
| metastatic disease | – | –Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery |
| follow up disease | – | –Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will be composed of a series of consecutive cancer patients who meet the study eligibility criteria in each participating centre
Key inclusion criteria (6 listed)
- histologically confirmed diagnosis of breast cancer
- no previous primary or recurrent tumour
- ability to understand the language of the questionnaire
- mental fitness to complete a questionnaire
- 18 years of age or above
Key exclusion criteria (6 listed)
- no histologically confirmed diagnosis of breast cancer
- previous primary or recurrent tumour
- not mentally fit to complete a questionnaire
- not able to understand the language of the questionnaire
- younger than 18
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
Psychometric Properties of the EORTC QLQ-BR45
Time frame: baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)
Psychometric Properties of the EORTC QLQ-BR45 (scale structure, reliability, internal consistency, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer)
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 20 Jul 2022.
- Background: PubMed 8874337Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.
- Background: PubMed 31959345Bjelic-Radisic V, Cardoso F, Cameron D, Brain E, Kuljanic K, da Costa RA, Conroy T, Inwald EC, Serpentini S, Pinto M, Weis J, Morag O, Lindviksmoen Astrup G, Tomaszweksi KA, Pogoda K, Sinai P, Sprangers M, Aaronson N, Velikova G, Greimel E, Arraras J, Bottomley A; EORTC Quality of Life Group and Breast Cancer Group. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Ann Oncol. 2020 Feb;31(2):283-288. doi: 10.1016/j.annonc.2019.10.027. Epub 2019 Dec 18.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Vesna Bjelic-Radisic principal investigator
Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
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 Cancer and Quality of Life, run by Helios University Hospital Wuppertal at 1 site in Germany.
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 6 inclusion and 6 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 20 Jul 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 Germany. 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?
Psychometric Properties of the EORTC QLQ-BR45 (time frame: baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)). 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 NCT04018235, which also lists 2 linked publications.
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 20 Jul 2022.