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

Completed

• Conditions: Myelodysplastic Syndrome (MDS)
• Interventions: Other: Patient Treatment Preference Myelodysplasia Questionnaire; Other: Carer Treatment Preference Myelodysplasia Questionnaire; Other: Clinician Treatment Preference Myelodysplasia Questionnaire

• Registration Number: NCT05817331
• Lead Sponsor: Otsuka Australia Pharmaceutical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-28
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Status Verified: 2023-04
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Patient Treatment Preference Myelodysplasia Questionnaire	Patients with MDS
Carer	Carer Treatment Preference Myelodysplasia Questionnaire	Carers of patients with MDS
Clinician	Clinician Treatment Preference Myelodysplasia Questionnaire	Clinicians who treat MDS

Primary Outcome Measures

Name	Time	Method
Validation of the pTPMQ, cTPMQ and mTPMQ	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.

Trial Locations

Locations (1)

Calvary Mater Newcastle; 🇦🇺 Newcastle, New South Wales, Australia