Improving the Quality of Advanced Cancer Care With Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 605
- 试验地点
- 1
- 主要终点
- Patient resource use
研究概览
简要总结
RATIONALE: A disease management program may be more effective than standard therapy in improving quality of life and controlling symptoms in patients with cancer.
PURPOSE: This clinical trial is studying a disease management program to see how well it works compared with usual care in patients with stage III or stage IV lung cancer, stage III or stage IV pancreatic cancer, stage III or stage IV ovarian cancer, or stage III or stage IV colorectal cancer, and their caregivers.
详细描述
OBJECTIVES:
- To examine the effects of the expansion of the current disease-management program (DMP) in patients with stage III or IV lung pancreatic, ovarian, or colorectal cancer.
- To determine whether there is a difference in resource use (number of chemotherapy treatments in the last 30 days of life, number of emergency room visits, number of days of hospice and hospitalization) among patients who have participated in a DMP compared to those receiving usual care.
- To determine whether there is a difference in patient outcomes (health-related quality of life, spiritual well being, satisfaction with care) among patients who have participated in a DMP compared to those receiving usual care.
- To determine whether there is a difference in caregiver outcomes (mood state, satisfaction with care, satisfaction with end-of-life care, and burden of care giving) among caregivers of patients who have participated in a DMP compared to those receiving usual care.
- To determine whether differences in patient and caregiver outcomes remain after controlling for the influence of demographic, clinical, and organizational covariates.
- To determine the extent of differences in patient and caregiver outcomes achieved through improvements in collaboration and problem solving.
OUTLINE: Patients are stratified according to type of current supportive care (usual care vs comprehensive disease-management program [DMP]).
- Usual care (control group): Patients undergo usual care as determined by core cancer team.
- DMP (experimental group): Patients undergo a systematic approach regarding specific domains related to their disease, focusing on supportive care and symptom management determined by a multidisciplinary team of providers to help patients and caregivers manage.
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months. Patients who transfer to hospice/palliative care treatment complete an additional questionnaire at the time of transfer and 3 weeks after transfer. If a patient death occurs during study, the caregiver is interviewed at 2 months after death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient resource use
时间窗: at the end of the patient's participation in the study and via monthly hospital and clinical chart review.
Symptoms
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Proportion of patients meeting expectations regarding care and treatment
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver burden
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patient spiritual well-being
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Proportion of caregivers meeting expectations regarding care and treatment
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver's satisfaction with end-of-life care
时间窗: caregiver is interviewed at 2 months after death.
Quality of life
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver mood state
时间窗: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
次要结局
未报告次要终点