Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2020-11-02
2022-01-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
EORTC QLQ-BR45 questionnaire
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.
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.
EORTC QLQ-BR45 questionnaire
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.
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.
EORTC QLQ-BR45 questionnaire
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.
Interventions
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EORTC QLQ-BR45 questionnaire
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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The Leeds Teaching Hospitals NHS Trust
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
University of Leeds
OTHER
Responsible Party
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Galina Velikova
Professor of Psycho-social and Medical Oncology/Consultant in Medical Oncology
Principal Investigators
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Galina Velikova
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Countries
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Related Links
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Webpage with brief study description
Other Identifiers
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275142
Identifier Type: -
Identifier Source: org_study_id