Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 559
- 试验地点
- 2
- 主要终点
- The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
研究概览
简要总结
The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.
详细描述
We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients diagnosed within 1 year with advanced cancer (stage IV), aged 40 years or older.
- •Patients must be cognitively intact at time of enrollment.
- •Patient need not have family care-giver to be enrolled, but if there is one, FCG is enrolled with the patient. FCG need not be 40 years of age.
排除标准
- •Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.
结局指标
主要结局
The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
时间窗: one year
次要结局
- To assess the efficacy of the intervention among patients in coping and decisions around end of life.(two years)