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CompletedNCT05817331TPMQUpdated Apr 18, 2023

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

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

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
16
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Myelodysplastic Syndrome (MDS)
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In context

Preleukemia

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Eligibility criteria

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:

Exclusion Criteria

A. Patients meeting any of the following criteria are excluded:

  1. They have lower risk disease (international prognostic scoring system low or intermediate-1 risk)
  2. Cognitive or physical impairment of a nature that makes it infeasible for them to effectively participate in a structured interview.
  3. Deemed appropriate for stem cell transplantation and are being pre-treated or will be treated with azacitidine
  4. They were treated, are being treated, or will be treated with azacitdine as part of a clinical trial
  5. They are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).

B. Carers meeting any of the following criteria are excluded:

  1. They are a caregiver of a patient who meets any of the exclusion criteria listed above in A
  2. They are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).

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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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient

    Patients with MDS

    Other: Patient Treatment Preference Myelodysplasia Questionnaire

  • Carer

    Carers of patients with MDS

    Other: Carer Treatment Preference Myelodysplasia Questionnaire

  • Clinician

    Clinicians who treat MDS

    Other: Clinician Treatment Preference Myelodysplasia Questionnaire

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

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Calvary Mater Newcastle
    Newcastle, New South Wales, Australia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05817331
Lead sponsor
Otsuka Australia Pharmaceutical Pty Ltd
Responsible party
Sponsor
First posted
Apr 18, 2023
Start date
Jun 28, 2022
Primary completion
Mar 10, 2023
Completion
Mar 10, 2023
Last update
Apr 18, 2023

Study contacts

Anoop K Enjeti, MBBS FRCP FRCPA PhD
principal investigator · Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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