A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients able to self-administer
研究概览
简要总结
This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.
详细描述
Chemotherapy for malignancies is predominantly prescribed and delivered in a tertiary hospital and/or cancer centre setting. However, with modern chemotherapy, with a reduced side effect profile, this paradigm should be challenged. Indeed, the use of methotrexate and other biologics (a form of chemotherapy) in the Rheumatologic setting is commonly delivered effectively and safely in the community.
Taken together, a hospital-based model of chemotherapy delivery may not be warranted in all circumstances. Moreover, the use of this current model invariably discounts the time commitments, needs of patients and caregivers, as well as while not addressing the emerging concerns regarding system capacity, efficiency and effectiveness of safe chemotherapy delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients are aged 18 years old or older with a diagnosis of symptomatic myeloma,
- •Stable clinical status as deemed by responsible investigator,
- •Personally (or caregiver) willing and deemed capable to self-administer with teaching,
- •Previously received more than 4 injections of bortezomib within the hospital and/or cancer centre environment,
- •Signed informed consent.
排除标准
- •Currently participating in clinical trials that includes the use of bortezomib,
- •History of allergic reactions to bortezomib,
- •History of bleeding attributable to bortezomib,
- •History of greater than or equal to grade 3 side effects attributable to bortezomib,
- •Clinically deemed unlikely to be compliant with therapy by responsible investigator,
- •Life expectancy anticipated to be less than 6 months,
- •Deemed geographically inaccessible to receive care.
研究组 & 干预措施
Self Injection of Bortezomib
Subcutaneous self administration of bortezomib
干预措施: Bortezomib Injection (Drug)
结局指标
主要结局
Number of patients able to self-administer
时间窗: 2 years from study start
Number of eligible patients availing of self-administration
Myeloma response outcomes
时间窗: 2 years from study start
Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented.
Number of patients with missed doses
时间窗: 2 years from study start
Proportion of missed doses
Adverse events great than grade 3
时间窗: 2 years from study start
Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3
Patient Satisfaction and Quality of Life Survey 1
时间窗: 2 years from study start
Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy)
Patient Satisfaction and Quality of Life Survey 2
时间窗: 2 years from study start
Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)
Patient Satisfaction and Quality of Life Survey 3
时间窗: 2 years from study start
Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life)
次要结局
未报告次要终点