Integration of Palliative Care for Cancer Patients on Phase I Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- Retention on the Phase I trial
研究概览
简要总结
This pilot randomized clinical trial studies palliative care intervention in improving quality of life, psychological distress, and communication in patients with solid tumors receiving treatment on phase I trials. Cancer patients experience many symptoms related to treatment and the cancer itself that can be distressing and impact quality of life. Palliative care focuses on managing these symptoms and may help patients with solid tumors live more comfortably.
详细描述
PRIMARY OBJECTIVES:
I. Test the effects of a palliative care intervention (PCI) on patients' quality of life (QOL), psychological distress and satisfaction with communication, comparing the experimental versus control groups.
II. Test the effects of a PCI on patients' symptom intensity and symptom interference with daily activities, comparing the experimental versus control groups.
III. Test the effects of a PCI on patients' hospital and palliative care resource utilization and clinical trial retention rates, comparing the experimental versus control groups.
IV. Test the effects of the timing of PCI initiation (early versus delayed) on patient outcomes, comparing the experimental versus control groups.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with solid tumors who are eligible for participation in Phase I clinical trials of investigational cancer therapies
- •Patients who have signed an informed consent for participation in Phase I clinical trials
- •Able to read or understand English-this is included because the intervention and study materials (including outcome measures) are only in English
- •Ability to read and/or understand the study protocol requirements, and provide written informed consent
排除标准
- •Patients diagnosed with hematologic (as a population distinct from solid tumors and different trials) cancers.
结局指标
主要结局
Retention on the Phase I trial
时间窗: 12 weeks
Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention.
Change in overall QOL scores, assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp)
时间窗: Baseline to 12 weeks
To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 and 12 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05. If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).
Change in psychological distress, assessed using the Psychological Distress Thermometer
时间窗: Baseline to 12 weeks
Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 4 and 12-week between the PCI and control groups, controlling for baseline psychological distress.
Satisfaction with communication, measured by the Family Satisfaction with Advanced Cancer Care (FAMCARE)
时间窗: 12 weeks
Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), at 4 and 12-week between the PCI and control groups, controlling for baseline satisfaction.
Total number of hospice referrals
时间窗: 12 weeks
Contingency table analysis with the chi square statistic to examine the association between group and hospice referral.
Patients' symptom intensity and symptom interference with daily activities
时间窗: 12 weeks
Analyzed using a 2x2 repeated measures ANCOVA to test for differences in symptom intensity and symptom interference with daily activities (using Psychological Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO - CTCAE) scores), at 4 and 12-week between the PCI and control groups, controlling for baseline symptom intensity and symptom interference.
Patient satisfaction with the PCI
时间窗: 12 weeks
Descriptive statistics and comparisons between the two groups will be conducted for overall satisfaction with intervention content and timing of the intervention.
Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist)
时间窗: 12 weeks
Contingency table analysis and the chi square statistic will be used to examine the association between group and referral to various support services. In addition, total number of referrals will be counted and an independent student's t-test will be used to test for significant differences in number of total referrals between groups.
Total number of unscheduled outpatient encounters and inpatient admissions
时间窗: 12 weeks
Total number of encounters and admissions will be counted and an independent student's t-test for each variable will be used to test for significant differences in number of total encounters and number of unscheduled admissions between groups.
次要结局
- Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist)(Up to 24 weeks)
- Total number of hospice referrals(Up to 24 weeks)
- Satisfaction with communication, measured by FAMCARE(Up to 24 weeks)
- Change in psychological distress, assessed using the Psychological Distress Thermometer(Baseline to 24 weeks)
- Patient satisfaction with the PCI(Up to 24 weeks)
- Patients' symptom intensity and symptom interference with daily activities(Up to 24 weeks)
- Change in overall QOL scores, assessed by FACT-G and FACIT-Sp(Baseline to 24 weeks)
- Total number of unscheduled outpatient encounters and inpatient admissions(Up to 24 weeks)
- Retention on the Phase I trial(Up to 24 weeks)