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

NCT ID: NCT05817331

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-28

Study Completion Date

2023-03-10

Brief Summary

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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

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Conditions

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Myelodysplastic Syndrome (MDS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient

Patients with MDS

Patient Treatment Preference Myelodysplasia Questionnaire

Intervention Type OTHER

Patient-reported outcome measure (PROM) in MDS

Carer

Carers of patients with MDS

Carer Treatment Preference Myelodysplasia Questionnaire

Intervention Type OTHER

Caregiver-reported outcome measure in MDS

Clinician

Clinicians who treat MDS

Clinician Treatment Preference Myelodysplasia Questionnaire

Intervention Type OTHER

Clinician-reported outcome measure in MDS

Interventions

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Carer Treatment Preference Myelodysplasia Questionnaire

Caregiver-reported outcome measure in MDS

Intervention Type OTHER

Clinician Treatment Preference Myelodysplasia Questionnaire

Clinician-reported outcome measure in MDS

Intervention Type OTHER

Patient Treatment Preference Myelodysplasia Questionnaire

Patient-reported outcome measure (PROM) in MDS

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

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:

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:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Australia Pharmaceutical Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anoop K Enjeti, MBBS FRCP FRCPA PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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2021_PID02858

Identifier Type: OTHER

Identifier Source: secondary_id

393-419-00045

Identifier Type: -

Identifier Source: org_study_id

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