Assessing Efficacy of an Occupational Therapy Fatigue Management-Based Intervention for Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Fatigue Inventory Score
研究概览
简要总结
This clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic). Many patients diagnosed with cancer experience cancer-related fatigue. These patients that are also on immunotherapy can experience added distressing fatigue that impacts their daily lives. Occupational therapy uses a client-centered and holistic approach to work collaboratively with patients to assess fatigue and develop strategies to manage each individual's specific needs. Fatigue-based management is a fundamental component of occupational therapy rehabilitation regimens. This trial may help patients address and reduce their fatigue.
详细描述
PRIMARY OBJECTIVE:
I. To determine if an occupational therapy (OT)-based intervention can reduce cancer-related fatigue by 10 percent as measured by the brief fatigue inventory (BFI) tool, in patients undergoing immunotherapy for metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
I. To determine if an OT-based intervention can improve pain ratings. II. To determine if an OT-based intervention can improve indices of depression. III. To determine if an OT-based intervention can improve indices of anxiety. IV. To determine if an OT-based intervention can maintain a reduced level of fatigue beyond the period of intervention.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Aged 18 and over.
- •Sufficiently fluent in English.
- •Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC).
- •Evidence of metastatic disease.
- •Clinician assessed prognosis of greater than or equal to six months.
- •Patients who are undergoing immunotherapy treatment (with a checkpoint inhibitor) for advanced kidney cancer who have grade 1 or 2 fatigue based on physician assessment at the time of study entry.
- •Willing and independently able to provide consent.
排除标准
- 未提供
结局指标
主要结局
Fatigue Inventory Score
时间窗: Baseline up to 5 weeks
Percentage of patients with a 10 percent or greater reduction in brief fatigue inventory score. Brief Fatigue Inventory is scored on an 10 points scale (0 to 10), with higher scores indicating worse outcomes.
次要结局
- Pain ratings(Baseline up to 5 and 12 weeks)
- Depression(From baseline to 5 and 12 weeks)
- Anxiety(From baseline to 5 and 12 weeks)
- Fatigue Inventory Score(At 12 weeks)