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Refine and Assess the Readability of Patient, Carer, and Clinician Treatment Preference in Myelodysplasia Questionnaire

Qualitative Interviews to Refine and Assess the Importance of Constructs, and Ensure the Readability of Patient, Carer, and Clinician Versions of the Treatment Preference in Myelodysplasia Questionnaire (TPMQ): pTPMQ, cTPMQ, and mTPMQ, Respectively

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05817331
Acronym
TPMQ
Enrollment
16
Registered
2023-04-18
Start date
2022-06-28
Completion date
2023-03-10
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome (MDS)

Brief summary

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.

Interventions

OTHERCarer Treatment Preference Myelodysplasia Questionnaire

Caregiver-reported outcome measure in MDS

OTHERClinician Treatment Preference Myelodysplasia Questionnaire

Clinician-reported outcome measure in MDS

OTHERPatient Treatment Preference Myelodysplasia Questionnaire

Patient-reported outcome measure (PROM) in MDS

Sponsors

Otsuka Australia Pharmaceutical Pty Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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: 1. They are currently being treated with azacitidine or 2. They have recently been treated with azacitidine or 3. They have been deemed eligible for treatment with azacitidine, but have not yet commenced treatment 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:

Design outcomes

Primary

MeasureTime frameDescription
Validation of the pTPMQ, cTPMQ and mTPMQEach participant is interviewed once for approximately 45 - 60 minutesObservational 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026