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

Myelodysplastic Syndrome (MDS) Clinical Trial

— TPMQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817331
• Other study ID #: 393-419-00045
• Secondary ID: 2021_PID02858
• Status: Completed
• Start date: June 28, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: April 2023
• Source: Otsuka Australia Pharmaceutical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Other:
• Carer Treatment Preference Myelodysplasia Questionnaire
Caregiver-reported outcome measure in MDS
• Clinician Treatment Preference Myelodysplasia Questionnaire
Clinician-reported outcome measure in MDS
• Patient Treatment Preference Myelodysplasia Questionnaire
Patient-reported outcome measure (PROM) in MDS

Locations

Country	Name	City	State
Australia	Calvary Mater Newcastle	Newcastle	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Australia Pharmaceutical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Each participant is interviewed once for approximately 45 - 60 minutes