NCT05817331已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Validation of the pTPMQ, cTPMQ and mTPMQ
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Validation of the pTPMQ, cTPMQ and mTPMQ
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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