A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Average total FACT-G score
研究概览
简要总结
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family. The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers. The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment. The team can make referrals to other specialists. Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
详细描述
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
- To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
- To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
- To compare caregiver burden and quality of life between the study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
- •Patients are eligible to enroll on this study with or without the enrollment of their caregiver.
排除标准
- •Patients diagnosed with a hematologic malignancy.
- •Caregiver Inclusion Criteria:
- •Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
- •Caregivers must be willing to complete surveys at baseline and on monthly basis.
- •Caregiver Exclusion Criteria:
- •Caregivers who are solely professional, paid caregivers
研究组 & 干预措施
Standard Supportive Care
干预措施: Standard supportive care (Behavioral)
Structured Supportive Care
干预措施: Structured palliative care (Behavioral)
结局指标
主要结局
Average total FACT-G score
时间窗: Up to 6 months
Measure patient quality of life
Average total MSAS score
时间窗: Up to 6 months
Assessment of patient burden
Duration on Study
时间窗: Up to 6 months
Measure of central tendency of the duration patients were on the phase I study. Duration on study will serve as the primary objective for sample size determination
Reason for study discontinuation (Patient reported outcome)
时间窗: Up to 6 months
Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
Adverse events
时间窗: Up to 6 months
Measure of central tendency of adverse events. AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities). The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed. An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE \* GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event. These scores will be compared between study arms
次要结局
- Mean number of hours of palliative care services(Up to 6 months)
- Type of palliative care services(Up to 6 months)