NCT06452446进行中（未招募）不适用
Telehealth-based Symptom Management for Veterans Treated With Selinexor
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The purpose of this study is to find out if continued monitoring of side effects from Selinexor and prescribed medication to prevent side effects helps improve symptoms, quality of life, and ability to continue the treatment longer.
详细描述
The primary objective of this study is to evaluate control of treatment-related and cancer-associated symptoms over the first three months of therapy with selinexor in Veterans who participate in a telehealth symptom management intervention.
The secondary objectives are:
- To describe characteristics of patients treated with selinexor.
- To describe adherence with the telehealth intervention.
- To define the type and frequency of adverse events that patients experience while taking selinexor.
- To describe the duration of selinexor therapy and evaluate adherence and dose intensity of selinexor in VA cancer patients receiving a telehealth symptom management intervention.
- To describe concomitant medication usage in patients treated with selinexor.
- To assess quality of life in patients treated with selinexor in the VA.
- To estimate progression-free survival in VA cancer patients treated with selinexor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of B-cell malignancy: either relapsed or refractory multiple myeloma or diffuse large B-cell lymphoma, meeting the FDA-approved indication for Selinexor treatment.
- •Requiring therapy as assessed by the treating oncology provider.
- •Prior authorization drug request for selinexor approved by VA oncology pharmacist.
- •Subject age 18 years or older.
- •Subject willing and able to perform video or telephone research visits.
- •Subjects must be able to read and comprehend English.
- •Subject must be a Veteran receiving cancer care from a VA facility affiliated with the National Teleoncology Program.
- •Patients must be enrolled prior to starting Selinexor.
排除标准
- •Any prior or current therapy with selinexor.
- •Any medical, psychiatric, or cognitive issue that the principal investigator or the subject's oncologists believes would prevent participation or completion of the study.
- •Individuals who are vulnerable to coercion or undue influence.
- •Any individuals or populations that may temporarily or permanently require additional considerations include such as those susceptible to coercion or undue influence (e.g., patients with limited or no treatment options, socially and economically disadvantaged persons).
- •Current selinexor therapy that is part of an investigational clinical trial.
结局指标
主要结局
Primary Outcome Measure
时间窗: 2 years
• CTCAE: Common Terminology Criteria for Adverse Events, version 5.0, an adverse event measuring tool used in clinical trials.
次要结局
未报告次要终点
研究者
研究点 (1)
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