Calvary Mater Newcastle
Newcastle, New South Wales, Australia
NCT Number: NCT05817331
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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Notify Me18 year and older
All sexes
Observational
Newcastle, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Caregiver-reported outcome measure in MDS
Clinician-reported outcome measure in MDS
Patient-reported outcome measure (PROM) in MDS
Time frame: Each participant is interviewed once for approximately 45 - 60 minutes
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.
Otsuka Australia Pharmaceutical Pty Ltd
Industry
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
Acronym: TPMQ
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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