NCT07008820已完成不适用
Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年5月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Participant baseline clinical characteristics
研究概览
简要总结
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the quantitative phase will include either 1 or 2 and all of 3-6:
- •Low Risk Myelodysplastic Syndromes (LR MDS) erythropoietin stimulating agent (ESA) naïve non-transfusion dependent (NTD) patrticipants: identified with confirmed via bone marrow aspirate and < 5% blasts in bone marrow. Lower-risk is defined by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R), as follows:
- •Very low, low, or intermediate-risk (score ≤ 3.5) as assessed by IPSS-R
- •Low or intermediate-1 (score ≤ 1) as assessed by IPSS
- •Unexplained anemia with suspected MDS: identified anemia with general anemia (iron/vitamin deficiency, bleeding, renal, etc.) excluded
- •Participants with hemoglobin in the most recent blood test < 10.0 g/dl, or the average of hemoglobin < 10.0g/dl in the most recent 2 blood tests conducted within 30 days prior to enrollment in this study
- •Participants who are ≥ 18 years of age at the time of signing the informed consent form.
- •Participants who are able and willing to provide informed consent.
- •Participants who are able to complete the protocol requirements.
- •For the qualitative phase (approximately 10 participants), the inclusion criteria will also include:
- •1. Participants with severity scores of "moderate" or greater on at least one Patient Global Impression-Severity (PGI-S) item.
排除标准
- •Patients meeting the following criteria will be excluded:
- •Participants who have difficulty obtaining informed consent or execution of this study because of insufficient Japanese language proficiency.
- •Participants who are considered to have difficulty answering HRQoL questionnaires and/or responding to questions during cognitive interview
- •Participants who received red-blood cell transfusion (RBC-T) within 16 weeks prior to enrollment.
- •Note: RBC-T of 1 to 2 units within the 16 weeks prior to enrollment are allowed, provided those 1-2 RBC-T units are administered for an acute event/illness (i.e., surgical procedure, bleeding, infection) or presence of comorbidity (including cardiovascular, pulmonary, cerebrovascular), and not for the treatment of low hemoglobin (with or without symptoms) alone.
- •Participants who received prior drug treatment related to anemia; drugs include the following: erythropoiesis stimulating agent, erythroid maturation agent, hypomethylating agent, immunomodulatory drugs, immuno-suppressive agent.
- •Participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPN) according to World Health Organization (WHO) 2016 classification (i.e., chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, breakpoint cluster region-Abelson 12, juvenile myelomonocytic leukemia, MDS/MPN unclassifiable).
- •Participants with secondary MDS (i.e., MDS that is known to have arisen as a result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- •Participants with a known history of diagnosis of acute myeloid leukemia.
- •Participants with major surgery within 8 weeks prior to enrollment. Patients must have completely recovered from any previous surgery prior to enrollment.
- •Participants with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venus thrombosis within 6 months prior to enrollment. Note: prior superficial thrombophlebitis is not an exclusion criterion.
- •Participants who have any condition or receive concomitant medication that confounds the ability to interpret data from the study.
结局指标
主要结局
Participant baseline clinical characteristics
时间窗: Baseline
Participant quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ C30) patient reported outcome questionnaire
时间窗: Day 1
Participant anemia symptoms as assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An) patient reported outcome questionnaire
时间窗: Day 1
Symptom severity as assessed by the Patient Global Impression-Severity (PGI-S) patient reported outcome questionnaire
时间窗: Day 1
General health status of participants as assessed by the EQ-5D-5L patient reported outcome questionnaire
时间窗: Day 1
Participant baseline socio-demographics
时间窗: Baseline
次要结局
- Qualitative interview results(Up to 1 month)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot StudyRelapsed and/or Refractory Multiple MyelomaNCT03903406Multinational Center for Quality of Life Research, Russia40
已完成
不适用
A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their CaregiversQuality of LifeImplantable Cardiac DefibrillatorsICDsNCT01454817Icahn School of Medicine at Mount Sinai562
招募中
不适用
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025Radiation ToxicityChemotherapeutic ToxicityChemotherapy-induced Peripheral NeuropathyDelayed Wound HealingChronic PainRefractory PainNCT05417737Bernardino Clavo, MD, PhD105
已完成
不适用
Assessment of Symptoms and Consequences of Coloanal Continuity ReconstructionRectal CancerNCT03292289Centre Oscar Lambret65
已完成
不适用
Quality of Life in Patients Undergoing Total Pelvic ExenterationTotal ExenterationAnterior or Posterior Pelvic ExenterationGynecologic MalignanciesColorectal MalignanciesUrologic MalignanciesNCT00597805Memorial Sloan Kettering Cancer Center94