Myelodysplastic Syndrome (MDS)TPMQNCT05817331
Refine and Assess the Readability of Patient, Carer, and Clinician Treatment Preference in Myelodysplasia Questionnaire
An observational study of Myelodysplastic Syndrome (MDS), run by Otsuka Australia Pharmaceutical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- Carer Treatment Preference Myelodysplasia Questionnaire, Clinician Treatment Preference Myelodysplasia Questionnaire and Patient Treatment Preference Myelodysplasia Questionnaire
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Jun 2022to 10 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Adult patients with myelodysplastic syndrome meeting any one of the following criteria:
- They are currently being treated with azacitidine or
- They have recently been treated with azacitidine or
- 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).
- Clinician treating patients meeting all of the inclusion criteria (i.e. treats patients who meet criteria defined above in A).
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Patients meeting any of the following criteria are excluded:
- They have lower risk disease (international prognostic scoring system low or intermediate-1 risk)
- Cognitive or physical impairment of a nature that makes it infeasible for them to effectively participate in a structured interview.
- Deemed appropriate for stem cell transplantation and are being pre-treated or will be treated with azacitidine
- They were treated, are being treated, or will be treated with azacitdine as part of a clinical trial
Show all 12Show fewer
- They are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).
- Carers meeting any of the following criteria are excluded:
- They are a caregiver of a patient who meets any of the exclusion criteria listed above in A
- They are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).
- 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).
- Participants who are not fluent in English, or who cannot read or write in English will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- Carer Treatment Preference Myelodysplasia Questionnaire, Clinician Treatment Preference Myelodysplasia Questionnaire, Patient Treatment Preference Myelodysplasia Questionnaire
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carer Treatment Preference Myelodysplasia QuestionnaireOther
Caregiver-reported outcome measure in MDS
Clinician Treatment Preference Myelodysplasia QuestionnaireOther
Clinician-reported outcome measure in MDS
Patient Treatment Preference Myelodysplasia QuestionnaireOther
Patient-reported outcome measure (PROM) in MDS
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients with MDS Receives: Other: Patient Treatment Preference Myelodysplasia Questionnaire | |
| Carer | Carers of patients with MDS Receives: Other: Carer Treatment Preference Myelodysplasia Questionnaire | |
| Clinician | Clinicians who treat MDS Receives: Other: Clinician Treatment Preference Myelodysplasia Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant is interviewed once for approximately 45 - 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start28 Jun 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Australia Pharmaceutical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anoop K Enjeti, MBBS FRCP FRCPA PhD, Principal investigator, Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817331
- Sponsor's protocol ID
- 393-419-00045
- Other IDs
- 2021_PID02858
- Acronym
- TPMQ
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05817331
- Acronym / sponsor ID
- TPMQ / 393-419-00045
- Conditions
- Myelodysplastic Syndrome (MDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Otsuka Australia Pharmaceutical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Patient Treatment Preference Myelodysplasia QuestionnairePatients with MDS |
| Carer | – | Other: Carer Treatment Preference Myelodysplasia QuestionnaireCarers of patients with MDS |
| Clinician | – | Other: Clinician Treatment Preference Myelodysplasia QuestionnaireClinicians who treat MDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Adult patients with myelodysplastic syndrome meeting any one of the following criteria:
- They are currently being treated with azacitidine or
- They have recently been treated with azacitidine or
- They have been deemed eligible for treatment with azacitidine, but have not yet commenced treatment
Key exclusion criteria (12 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Patients meeting any of the following criteria are excluded:
- They have lower risk disease (international prognostic scoring system low or intermediate-1 risk)
- Cognitive or physical impairment of a nature that makes it infeasible for them to effectively participate in a structured interview.
- Deemed appropriate for stem cell transplantation and are being pre-treated or will be treated with azacitidine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carer Treatment Preference Myelodysplasia QuestionnaireCaregiver-reported outcome measure in MDS | Other | Carer |
| Clinician Treatment Preference Myelodysplasia QuestionnaireClinician-reported outcome measure in MDS | Other | Clinician |
| Patient Treatment Preference Myelodysplasia QuestionnairePatient-reported outcome measure (PROM) in MDS | Other | Patient |
Primary outcome
Validation of the pTPMQ, cTPMQ and mTPMQ
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop K Enjeti, MBBS FRCP FRCPA PhD principal investigator
Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome (MDS), run by Otsuka Australia Pharmaceutical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the pTPMQ, cTPMQ and mTPMQ (time frame: Each participant is interviewed once for approximately 45 - 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.