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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Rachel
Knight
rachel.knight@ucl.ac.uk
Sara
Fessehaye
sara.fessehaye@nhs.net
Prof
Stefano
Fedele
s.fedele@ucl.ac.uk
Rachel
Knight
rachel.knight@ucl.ac.uk
Diseases of oral cavity, salivary glands and jaws
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BACKGROUND
Medication-related osteonecrosis of the jaws (MRONJ) is an adverse reaction of a group of medications commonly used for the treatment of osteoporosis and bone cancer: bisphosphonates, denosumab and antiangiogenics. Affected individuals can develop area of irreversible bone necrosis ("dead bone") to the jaw bones, with consequent chronic pain, infection, tooth loss, bone fracture, dysfunction and disfigurement. Treatment options include long-term antibiotics and surgery. As MRONJ can cause significant morbidity, it is crucial to understand and measure the symptoms and experiences (quality of life) of affected individuals in order to assess the severity of the disease and related changes after treatment. A number of generic quality of life questionnaires have been used to assess patients' perception of MRONJ, however these generic instruments are not specific to the disease and unlikely to capture in detail the impact of the disease as perceived by patients. Therefore there is a need to develop a disease-specific quality of life questionnaire which includes aspects of health that are considered by patients or clinicians to be of greatest importance.
AIMS
The aim of DOMINO is to develop and test a patient-reported outcome measure (quality of life questionnaire) relevant to MRONJ, to be used in daily clinical practice and future research.
METHODS
The initial stages of questionnaire development will involve both clinical experts' and patient input, via qualitative interviews. Experts and patient's views will be used to develop a draft questionnaire. The newly developed draft MRONJ-specific instrument will then be tested and modified as needed in patients diagnosed with MRONJ in order to ensure that it does reflect aspects of the disease and related patient experience (a research methodology called psychometric testing).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Qualitative;
You can take part if:
You may not be able to take part if:
1) History of head and neck irradiation 2) Unable to consent 3) Unable to understand/speak English language
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Rachel
Knight
rachel.knight@ucl.ac.uk
Rachel
Knight
rachel.knight@ucl.ac.uk
Sara
Fessehaye
sara.fessehaye@nhs.net
Prof
Stefano
Fedele
s.fedele@ucl.ac.uk
The study is sponsored by University College London and funded by NIHR Central Commissioning Facility (CCF); Ministry of Education (Saudi Arabia); .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 49659
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