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

• Sponsor: Otsuka Australia Pharmaceutical Pty Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05817331
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Actual Duration (Months): 8.4
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome (MDS)	Other: Carer Treatment Preference Myelodysplasia Questionnaire; Other: Clinician Treatment Preference Myelodysplasia Questionnaire; Other: Patient Treatment Preference Myelodysplasia Questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Jun 28, 2022
• Actual Primary Completion Date: Mar 10, 2023
• Actual Study Completion Date: Mar 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patient Patients with MDS	Other: Patient Treatment Preference Myelodysplasia Questionnaire; Patient-reported outcome measure (PROM) in MDS
Carer Carers of patients with MDS	Other: Carer Treatment Preference Myelodysplasia Questionnaire; Caregiver-reported outcome measure in MDS
Clinician Clinicians who treat MDS	Other: Clinician Treatment Preference Myelodysplasia Questionnaire; Clinician-reported outcome measure in MDS

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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).

1. 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).

2. Participants who are not fluent in English, or who cannot read or write in English will be excluded from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Calvary Mater Newcastle	Newcastle	New South Wales	Australia

Sponsors and Collaborators

• Otsuka Australia Pharmaceutical Pty Ltd

Investigators

• Principal Investigator: Anoop K Enjeti, MBBS FRCP FRCPA PhD, Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Australia Pharmaceutical Pty Ltd
• ClinicalTrials.gov Identifier: NCT05817331
• Other Study ID Numbers: 393-419-00045; 2021_PID02858
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes

Study Results

No Results Posted as of Apr 18, 2023