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| ID | Type | Description | Link |
|---|---|---|---|
| 2021_PID02858 | Other Identifier | Otsuka Australia Pharmaceutical Pty Ltd |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Patients with MDS |
| |
| Carer | Carers of patients with MDS |
| |
| Clinician | Clinicians who treat MDS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carer Treatment Preference Myelodysplasia Questionnaire | Other | Caregiver-reported outcome measure in MDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each participant is interviewed once for approximately 45 - 60 minutes |
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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
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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
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| Name | Affiliation | Role |
|---|---|---|
| Anoop K Enjeti, MBBS FRCP FRCPA PhD | Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calvary Mater Newcastle | Newcastle | New South Wales | Australia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2026 | |
| Reset | Jan 29, 2026 |
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| Clinician Treatment Preference Myelodysplasia Questionnaire | Other | Clinician-reported outcome measure in MDS |
|
| Patient Treatment Preference Myelodysplasia Questionnaire | Other | Patient-reported outcome measure (PROM) in MDS |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2026 | Jan 29, 2026 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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