A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Referrals to Supportive Care Services
研究概览
简要总结
In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a patient navigator-led generalist palliative and supportive care intervention or in usual care led by their treating physician. The patient navigator will assess the patient's palliative and supportive care needs using standardized quality of life and symptoms questionnaires and present this assessment to a multidisciplinary team composed of oncologists and palliative care specialist. The multidisciplinary team will develop a personalized supportive care plan for the patient which will then be presented and discussed by the patient navigator. Those interventions which are accepted by the patient will be implemented by the patient navigator, who will also provide education and teaching. The patient navigator will also help eligible patients complete advanced directives according to local rules and regulations. The patient navigator will follow the patients both in person and by telephone to ensure that the recommended interventions have been implemented. Three months after enrollment the patients will undergo quality of life and symptom assessment once again, and the implementation of interventions will be recorded.
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
- 否
入选标准
- •Male or female patients 18 years of age and older
- •Newly diagnosed stage IV solid tumor
- •Recurrent stage IV solid tumor
排除标准
- •Homeless persons
- •History of drug abuse or alcoholism
- •Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders
- •Mentally disabled patients
- •Incarcerated patients
结局指标
主要结局
Referrals to Supportive Care Services
时间窗: Three months
Proportion of patients who agree to participate in the patient navigation program, complete the initial assessment, meet with the patient navigator to discuss advanced care planning and supportive care interventions and obtain the appropriate referrals and consultations.
次要结局
- Use of chemotherapy at the end of life(18 months)
- Changes in self-reported pain(Three months)
- Healthcare utilization(18 months)
- Rate of advanced directive completion(Three months)
- Survival(18 months)
- Implementation of planned supportive care interventions(Three months)
- Changes in QOL(Three months)
