Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 14
- 主要终点
- Quality of life (QoL)
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 investigators will enroll patients at two UPMC sites: Montefiore Hospital, an academic medical center, and Passavant Hospital, a community based hospital. Based on our sample size estimate the investigators will have at least 364 patients and caregivers with complete data at 12 months follow up.
The patient and caregiver will be randomly assigned to one of two arms (intervention versus enhanced usual care) stratified by gender and vessel invasion. Because these factors are the two most robust prognostic factors in this patient population. At 6 and 12 months after enrollment, follow-up questionnaires and blood draws will be performed for patients and caregivers.
The stepped WBCC 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. 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.
Intervention fidelity (e.g., consistency across care coordinators) will be reduced by requiring the care coordinators to follow a 300 page manual and providing standardized training by the PI who is a clinical psychologist. Dr. Steel (PI) has received training and certification from the American Psycho-Oncology Society in the design and analysis of psycho-oncology clinical trials and intervention fidelity. The study investigators will not prescribe any medications but rather make recommendations to the patient's oncologist, PCP, psychiatrist, or pain management specialist who will be free to accept or reject the recommendations by the study team. Medication type, dosage, and adherence to medication (e.g., self-report and pharmacy refills) will be recorded for patients in the WBCC intervention and enhanced usual care arms.
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
- 否
入选标准
- •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 at the UPMC's Liver Cancer Center and
- •age >21 years
排除标准
- •age < 21 years,
- •lack of fluency in English,
- •evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
- •Caregivers:
- •lack of fluency in English; and
- •evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
结局指标
主要结局
Quality of life (QoL)
时间窗: change from baseline at 6 and 12 months
Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
次要结局
- Caregivers' stress(change from baseline at 6 and 12 months)
- Caregiver's serum Interleukin-6(change from baseline at 6 and 12 months)
- serum Alpha feta protein (u/ml)(change from baseline at 6 months and 12 months)
- serum Interleukin (IL)-6,(mg/L)(change from baseline at 6 months and 12 months)
- Caregiver's blood pressure(change from baseline at 6 and 12 months)
- Caregivers' depression(change from baseline at 6 and 12 months)
- serum Cancer Antigen 19-9 (u/ml)(change from baseline at 6 months and 12 months)
- dyadic adjustment(change from baseline at 6 and 12 months)
- Caregiver's Body Mass Index(change from baseline at 6 and 12 months)
- serum Interleukin IL-1beta,(mg/L)(change from baseline at 6 and 12 months)
- serum Tumor necrosis factor-alpha ((mg/L)(change from baseline at 6 and 12 months)
- serum Inteferon-gamma ((mg/L)(change from baseline at 6 and 12 months)
- serum carcinoembryonic antigen (u/ml)(change from baseline at 6 months and 12 months)
- Depression(change from baseline at 6 and 12 months)
- Caregiver's metabolic syndrome(change from baseline at 6 and 12 months)
- Fatigue(change from baseline at 6 and 12 months)
- Pain level(change from baseline at 6 and 12 months)
研究者
Jennifer Steel
Director and Associate Professor
University of Pittsburgh