EORTC Metastatic Breast Cancer Module Development
ConditionMetastatic Beast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Leeds
About this trial
The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult females aged 18 years or over.
Have a diagnosis of MBC (Breast cancer that has spread to another part of the body), including de novo MBC patients. Patients with brain metastases will be included, providing there is no associated major cognitive impairment.
Have received (patients under observation) or currently receiving treatment for MBC, including chemotherapy, hormone therapy, targeted agents (anti-HER2, CDK4/6 inhibitors, mTOR/PIK3CA inhibitors, PARP inhibitors, immune therapy), radiotherapy and combinations.
Conversant in the language of questionnaire administration.
Disqualifiers
Patients diagnosed with early stage breast cancer.
Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation in interviews.
Patients previously involved in Phase I.
Trial population
Adult females with Metastatic breast cancer
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Quality of life of females with metastatic breast cancer
Time frame
1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov