Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Measure increased utilization (move from 18% to over 50%) of palliative medicine and increased proportion of patients receiving services more then 30 days before death as compared to historical controls.
研究概览
简要总结
This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.
详细描述
PRIMARY OBJECTIVES:
I. Validate a model of proactive palliative medicine referral. II. Quantify the impact of palliative care aggressive care at the end-of-life (PCARE) versus PCARE + idiographic assessment on quality of care and patient satisfaction.
III. Utilizing CMO data Investigators will create a cost model for patients randomized to PCARE versus patients refusing randomization.
IV. Determine the impact of a proactive model of palliative care consultation at the time of diagnosis on family/caregivers.
OUTLINE: Patients are randomized 1 of 2 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following:
- •< 30 % projected 5 year survival based on histopathological stage
- •Non-pelvic recurrent malignancy
- •Persistent or progressive disease despite primary treatment with surgery, chemotherapy or
- •Palliative performance scale < 60
- •Enrollment within 6 weeks of tumor board review
排除标准
- 未提供
研究组 & 干预措施
Palliative Therapy
EORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
干预措施: Palliative Therapy (Other)
Palliative Therapy
EORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
干预措施: Palliative Therapy + idiographic (Other)
Palliative Therapy+ idiographic
EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
干预措施: Palliative Therapy + idiographic (Other)
Palliative Therapy+ idiographic
EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
干预措施: Palliative Therapy (Other)
结局指标
主要结局
Measure increased utilization (move from 18% to over 50%) of palliative medicine and increased proportion of patients receiving services more then 30 days before death as compared to historical controls.
时间窗: Baseline
To validate a model of proactive palliative medicine referral; We recorded that proactive referral will result in a clinically relevant increase of utilization of palliative medicine services (\>70% of eligible women will have at least 1 consultation) and facilitate proxy assignment and improve pain/symptom control. There will be increased utilization of palliative care.
Measured by differential in aggresive care at end-of-life from direct hospital costs in the last 6 months of life between patients that are randomized and refuse randomization.
时间窗: Up to 3 years
We measured ACE and decreased direct hospital cost of care in the last 6 months of life between patients randomized and refusing randomization.
Evaluate costs related to procedures, laboratories, radiographic studies, intensive care admission, and blood transfusion to create a model of potential cost savings as generalized to patients with non-gynecologic cancers within the CMO.
时间窗: Up to 3 years
We utilized CMO data to create a cost model for patients randomized to PCARE versus patients refusing randomization. Costs related to potentially "preventable spends" will be obtained from the CMO database for eligible patients.
FAMCARE Survey will be administered, a 20 item scale measuring the degree to which family members are satisfied with the healthcare providers' behaviors. Comparison of family member scores between 2 arms, as well as at face value will be evaluated.
时间窗: up to 3 years
We administered a patient satisfaction scale
次要结局
未报告次要终点
研究者
Nicole Nevadunsky
Principal Investigator
Albert Einstein College of Medicine