Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Caregiver Quality of Life
研究概览
简要总结
To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.
详细描述
The intervention is designed to maintain quality of life for those in greatest need and least access to resources. This innovative and scalable web-based collaborative care intervention is expected not only to improve patients' quality of life, at the end of life, but also reduce caregiver stress and depression, and potentially health morbidity and mortality of patients and spousal and intimate partner caregivers from socioeconomically disadvantaged backgrounds. Study findings are expected to lead to research examining the dissemination and implementation of the intervention.
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
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients:
- •Biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year; age >21 years; no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported.
- •Caregivers:
- •A spouse or cohabitating intimate partner of an advanced cancer patient being evaluated the UPMC's Liver Cancer Center and age >21 years
排除标准
- •Patients:
- •Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
- •Caregivers:
- •Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
研究组 & 干预措施
Stepped collaborative care intervention
The 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds.
干预措施: Stepped collaborative care intervention (Behavioral)
Enhanced Usual Care
Patients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Caregiver Quality of Life
时间窗: Change from baseline at 6 months
Caregiver Quality of Life Questionnaire (CQOL)
Sleep Quality
时间窗: Change from baseline at 6 months
Pittsburgh Sleep Quality Index (PSQI)
Depression
时间窗: Change from baseline at 6 months
Center for Epidemiological Studies -Depression (CESD)
Fatigue
时间窗: Change from baseline at 6 months
Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)
Pain Level
时间窗: Change from baseline at 6 months
Brief Pain Inventory (BPI)
Functioning
时间窗: Change from baseline at 6 months
Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)
Stress
时间窗: Change from baseline at 6 months
Perceived Stress Scale (PSS)
次要结局
未报告次要终点
研究者
Jennifer Steel
Director and Associate Professor
University of Pittsburgh