CancerNCT04270123
An EORTC Study Updating the QLQ-BR23 to BR45
An observational study of Cancer and Breast Cancer, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Female 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 onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast Cancer
- What is being tested?
- EORTC QLQ-BR45 questionnaire
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2020to 31 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients
Who may be able to join
- Adult females aged 18 years or over
- Histologically confirmed diagnosis of breast cancer (any type) with no previous primary or recurrent tumour
- Receiving or have previously received curative or palliative treatment.
- Able to understand/speak English and complete the questionaires
- Have the capacity/mental fitness to give written informed consent and complete the questionnaires.
Who cannot join
- Male gender or transgender
- Inability to understand/speak English and complete the questionnaire
- Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
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 EORTC QLQ-BR45)
Female 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 Quality of life group 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 four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible.
Read more
According to sample size calculations, we will include a total of N =490 patients from 12 countries.
Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).
- Conditions
- Cancer, Breast Cancer
- Being tested
- EORTC QLQ-BR45 questionnaire
- Keywords
- EORTC, PRO, PROM, Adverse Event, Quality of Life
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-BR45 questionnaireOther
The EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 consists of breast cancer patients with local or locally advanced disease. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. A subgroup of participants within this group (those who have changed disease or treatment status) will be asked to complete the above questionnaires again, three months later (+-1 week). They will also complete an anchor question. Completing twice is for the responsiveness to change analysis. Receives: Other: EORTC QLQ-BR45 questionnaire | |
| Group 2 | Group 2 consists of metastatic breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires at one time point only. Receives: Other: EORTC QLQ-BR45 questionnaire | |
| Group 3 - follow up | Group 3 consists of follow up breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. One-to two weeks later, a subgroup of participants in this group (with no evidence of disease and /or change in health status) will complete the above questionnaires, as well as an anchor question. Completing twice is for the test-retest analysis. Receives: Other: EORTC QLQ-BR45 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC-BR45 questionnaire
This is a questionnaire validation study. No reporting score on scale.
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start2 Nov 2020
- Primary completion12 Jul 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, European Organisation for Research and Treatment of Cancer - EORTC
- Responsible party
- Principal investigator, Galina Velikova, University of Leeds
- Investigators
- Galina Velikova, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270123
- Sponsor's protocol ID
- 275142
- Status last verified
- Nov 2023
- First submitted
- 10 Feb 2020
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. 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 EORTC QLQ-BR45)
- ClinicalTrials.gov ID
- NCT04270123
- Acronym / sponsor ID
- 275142
- Conditions
- Cancer, Breast Cancer
- Keywords
- EORTC, PRO, PROM, Adverse Event, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 17 Feb 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.
Female 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 Quality of life group 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 four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible.
According to sample size calculations, we will include a total of N =490 patients from 12 countries.
Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: EORTC QLQ-BR45 questionnaireGroup 1 consists of breast cancer patients with local or locally advanced disease. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. A subgroup of participants within this group (those who have changed disease or treatment status) will be asked to complete the above questionnaires again, three months later (+-1 week). They will also complete an anchor question. Completing twice is for the responsiveness to change analysis. |
| Group 2 | – | Other: EORTC QLQ-BR45 questionnaireGroup 2 consists of metastatic breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires at one time point only. |
| Group 3 - follow up | – | Other: EORTC QLQ-BR45 questionnaireGroup 3 consists of follow up breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. One-to two weeks later, a subgroup of participants in this group (with no evidence of disease and /or change in health status) will complete the above questionnaires, as well as an anchor question. Completing twice is for the test-retest analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients
Key inclusion criteria (5 listed)
- Adult females aged 18 years or over
- Histologically confirmed diagnosis of breast cancer (any type) with no previous primary or recurrent tumour
- Receiving or have previously received curative or palliative treatment.
- Able to understand/speak English and complete the questionaires
- Have the capacity/mental fitness to give written informed consent and complete the questionnaires.
Key exclusion criteria (3 listed)
- Male gender or transgender
- Inability to understand/speak English and complete the questionnaire
- Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-BR45 questionnaireThe EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer. | Other | Group 1, Group 2, Group 3 - follow up |
Primary outcome
EORTC-BR45 questionnaire
Time frame: 2020-2021
This is a questionnaire validation study. No reporting score on scale.
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 1 Dec 2023.
- Webpage with brief study descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
Galina Velikova principal investigator
University of Leeds
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 Cancer and Breast Cancer, run by University of Leeds at 1 site in United Kingdom.
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 5 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 1 Dec 2023. 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 United Kingdom. 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?
EORTC-BR45 questionnaire (time frame: 2020-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.