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OpenTrials
Completed

NCT Number: NCT05817331

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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:

  • 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 caregiver of a patient who meets any of the exclusion criteria listed above in A
  • 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

Treatment and study plan

Carer Treatment Preference Myelodysplasia Questionnaire

Other

Caregiver-reported outcome measure in MDS

Clinician Treatment Preference Myelodysplasia Questionnaire

Other

Clinician-reported outcome measure in MDS

Patient Treatment Preference Myelodysplasia Questionnaire

Other

Patient-reported outcome measure (PROM) in MDS

Primary outcomes

  1. Validation of the pTPMQ, cTPMQ and mTPMQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Otsuka Australia Pharmaceutical Pty Ltd

Industry

Registry information

Official study 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

Acronym: TPMQ

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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