Clinical trial NCT05817331: Refine and Assess the Readability of Patient, Carer, and Clinician Treatment Preference in Myelodysplasia Questionnaire
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome (MDS)
Lead sponsor: Otsuka Australia Pharmaceutical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


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

Primary outcomes:
measure: Validation of the pTPMQ, cTPMQ and mTPMQ
timeFrame: Each participant is interviewed once for approximately 45 - 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
Study officials:
affiliation: Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia
name: Anoop K Enjeti, MBBS FRCP FRCPA PhD
role: PRINCIPAL_INVESTIGATOR
References: