A Randomized Trial of a Family Caregiver Palliative Care Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effects of FCPCI on Quality Of Life (QOL)
研究概览
简要总结
This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.
详细描述
PRIMARY OBJECTIVES: I. Test the effects of the Family Caregiver Palliative Care Intervention (FCPCI) on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on caregiver burden and caregiving skills preparedness as compared to family caregivers in the control group.
II. Test the effects of the FCPCI on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on quality of life (QOL) and psychological distress as compared to family caregivers in the control group.
SECONDARY OBJECTIVES: I. Describe family caregivers' self-care behavior, comparing the experimental and control groups.
II. Describe family caregivers' resource use, comparing the experimental and control groups.
III. Identify subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary or lung cancers who are entering the City of Hope for treatment or follow-up
- •Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease
- •Primary family caregivers of cancer patients with > 6 months prognosis
- •Living within a 50 mile radius of the City of Hope
排除标准
- 未提供
研究组 & 干预措施
Arm I (FCPCI)
Participants receive FCPCI with an APN, comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.
干预措施: educational intervention (Other)
Arm I (FCPCI)
Participants receive FCPCI with an APN, comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.
干预措施: telephone-based intervention (Behavioral)
Arm I (FCPCI)
Participants receive FCPCI with an APN, comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.
干预措施: quality-of-life assessment (Procedure)
Arm I (FCPCI)
Participants receive FCPCI with an APN, comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.
干预措施: questionnaire administration (Other)
Arm II (usual care)
Participants receive usual care.
结局指标
主要结局
Effects of FCPCI on Quality Of Life (QOL)
时间窗: Up to 6 months
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Effects of FCPCI on psychological distress
时间窗: Up to 6 months
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
时间窗: Up to 6 months
Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).
Effects of FCPCI on caregiving skills preparedness
时间窗: Up to 6 months
ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.
次要结局
- Family caregivers' satisfaction with the FCPCI(6 months)
- Caregivers' resource use(Up to 6 months)
- Caregiver out-of-pocket costs(Up to 6 months)
- Caregiver's self-care behavior(Up to 6 months)
- Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics(3 months)