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

NCT05817331 | Completed

• 2 other identifiers: 393-419-000452021_PID02858
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome (MDS)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Patient

Patients with MDS

Other: Patient Treatment Preference Myelodysplasia Questionnaire

Carer

Carers of patients with MDS

Other: Carer Treatment Preference Myelodysplasia Questionnaire

Clinician

Clinicians who treat MDS

Other: Clinician Treatment Preference Myelodysplasia Questionnaire

Interventions

Carer Treatment Preference Myelodysplasia Questionnaire OTHER

Caregiver-reported outcome measure in MDS

Carer

Clinician Treatment Preference Myelodysplasia Questionnaire OTHER

Clinician-reported outcome measure in MDS

Clinician

Patient Treatment Preference Myelodysplasia Questionnaire OTHER

Patient-reported outcome measure (PROM) in MDS

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• They are currently being treated with azacitidine or
• They have recently been treated with azacitidine or
• They have been deemed eligible for treatment with azacitidine, but have not yet commenced treatment

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• A. Patients meeting any of the following criteria are excluded:
• They have lower risk disease (international prognostic scoring system low or intermediate-1 risk)
• Cognitive or physical impairment of a nature that makes it infeasible for them to effectively participate in a structured interview.
• Deemed appropriate for stem cell transplantation and are being pre-treated or will be treated with azacitidine
• They were treated, are being treated, or will be treated with azacitdine as part of a clinical trial
• 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:
• 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

Sponsors & Collaborators

• Otsuka Australia Pharmaceutical Pty Ltd: lead

Study Sites (1)

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Anoop K Enjeti, MBBS FRCP FRCPA PhD

  Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: June 28, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)