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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05817331




Registration number
NCT05817331
Ethics application status
Date submitted
4/04/2023
Date registered
18/04/2023
Date last updated
18/04/2023

Titles & IDs
Public title
Refine and Assess the Readability of Patient, Carer, and Clinician Treatment Preference in Myelodysplasia Questionnaire
Scientific 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
Secondary ID [1] 0 0
2021_PID02858
Secondary ID [2] 0 0
393-419-00045
Universal Trial Number (UTN)
Trial acronym
TPMQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndrome (MDS) 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Carer Treatment Preference Myelodysplasia Questionnaire
Other interventions - Clinician Treatment Preference Myelodysplasia Questionnaire
Other interventions - Patient Treatment Preference Myelodysplasia Questionnaire

Patient - Patients with MDS

Carer - Carers of patients with MDS

Clinician - Clinicians who treat MDS


Other interventions: Carer Treatment Preference Myelodysplasia Questionnaire
Caregiver-reported outcome measure in MDS

Other interventions: Clinician Treatment Preference Myelodysplasia Questionnaire
Clinician-reported outcome measure in MDS

Other interventions: Patient Treatment Preference Myelodysplasia Questionnaire
Patient-reported outcome measure (PROM) in MDS
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Validation of the pTPMQ, cTPMQ and mTPMQ
Timepoint [1] 0 0
Each participant is interviewed once for approximately 45 - 60 minutes

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/03/2023
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment postcode(s) [1] 0 0
- Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Otsuka Australia Pharmaceutical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05817331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anoop K Enjeti, MBBS FRCP FRCPA PhD
Address 0 0
Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries