An observational study in Myelodysplastic Syndrome (MDS), sponsored by Otsuka Australia Pharmaceutical Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Otsuka Australia Pharmaceutical Pty Ltd · Observational
The primary goal of this study is to use qualitative interviews to elicit and confirm concepts related to treatment preferences and understandability of the pTPMQ, cTPMQ, and mTPMQ. The information gathered will be used to support the appropriateness of the questionnaires as a patient-reported, caregiver-reported and clinician-reported outcome measure (PROM) in the population of interest.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 16 is below the median of 114 across 116 observational studies indexed under Preleukemia.
Browse Preleukemia studies →Otsuka Australia Pharmaceutical Pty Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with myelodysplasia who are eligible for treatment with azacitidine or are being treated with azacitidine or have been treated with azacitidine, and Primary carers of the patients such as those mentioned above, and Clinicians who treat patients such as those mentioned above
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
A. Adult patients with myelodysplastic syndrome meeting any one of the following criteria:
B: Primary caregiver of a patient meeting all of the inclusion criteria (i.e. a patient who meets criteria defined above in A).
C. Clinician treating patients meeting all of the inclusion criteria (i.e. treats patients who meet criteria defined above in A).
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Exclusion Criteria
A. Patients meeting any of the following criteria are excluded:
B. Carers meeting any of the following criteria are excluded:
C. Clinician will be excluded from participating in the study if a relative of an employee of the sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).
D. Participants who are not fluent in English, or who cannot read or write in English will be excluded from the study
Patients with MDS
Other: Patient Treatment Preference Myelodysplasia Questionnaire
Carers of patients with MDS
Other: Carer Treatment Preference Myelodysplasia Questionnaire
Clinicians who treat MDS
Other: Clinician Treatment Preference Myelodysplasia Questionnaire
Caregiver-reported outcome measure in MDS
Clinician-reported outcome measure in MDS
Patient-reported outcome measure (PROM) in MDS
Validation of the pTPMQ, cTPMQ and mTPMQ
Observational qualitative study consisting of interviews with MDS participants. The study endpoints are an assessment of understanding of the questions, response options and directions, as described in the ISPOR patient-reported outcome measure (PROM) guidance.
Time frame: Each participant is interviewed once for approximately 45 - 60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Otsuka Australia Pharmaceutical Pty Ltd