EORTC Metastatic Breast Cancer Module Development
Recruiting · NCT07806266 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- Have the capacity to give informed consent.
Exclusion criteria
- 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.
Where it is running
22 locations listed.
- King Hussein Cancer Center - Amman, Jordan
- NKI-AVL Amsterdam - Amsterdam, Netherlands
- Charité - Universitätsmedizin - Berlin, Germany
- Comenius University and National Cancer Institute - Bratislava, Slovakia
- Ghent University Hospital - Ghent, Belgium
- St James University hospital - Leeds, United Kingdom
- Champalimaud Clinical Centre - Lisbon, Portugal
- Centre Hospitalier Lyon Sud - Lyon, France
- Centre hospitalier de l'Université de Montreal - Montreal, Canada
- Tata Memorial Hospital - Mumbai, India
- Istituto Nazionale Tumori - Naples, Italy
- University Hospital of Nimes - Nîmes, France
- Kansai Medical University Hospital - Osaka, Japan
- Veneto Institute of Oncology - Padova, Italy
- Royal Navarre Hospital - Pamplona, Spain
- Mount Vernon Cancer Centre - Rickmansworth, United Kingdom
- Centre Hospitalier Universitaire de Saint-Etienne - Saint-Etienne, France
- National Cancer Centre Hospital - Tokyo, Japan
- National Centre for Global Health and Medicine - Tokyo, Japan
- Odette Cancer Center - Sunnybrook Health Sciences Center - Toronto, Canada
- Maria Sklodowska Curie National Research Institute of Oncology - Warsaw, Poland
- Helios University Hospital - Wuppertal, Germany