The Effects of a Sensorimotor Rehabilitation Program on the Upper and Lower Limbs of Persons With Cancer Following Taxane-Based Chemotherapy for Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evaluate patients using post-test scores on the CIPN-20
研究概览
简要总结
This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.
详细描述
PRIMARY OBJECTIVES:
I. To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.
OUTLINE:
Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
- •Taxane-based chemotherapy for early stage breast cancer
- •Diagnosis of early stage breast cancer
排除标准
- •Individuals with late stage breast cancer
结局指标
主要结局
Evaluate patients using post-test scores on the CIPN-20
时间窗: Up to 2 years
The purpose of the CIPN-20 is to identify quality of life. Twenty items are used to identify symptoms and functional limitations related to CIPN. Three subscales represent sensory, motor, and autonomic function and provide a more complete picture of the nature, frequency, and severity of CIPN. The CIPN-20 is a multidimensional scale that was specifically developed to capture patients' symptoms and functional limitations as related to CIPN 11,12. The CIPN-20 is best utilized when combined with other pain and quality of life tools.
Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores
时间窗: Up to 2 years
The purpose of the Quick-DASH is to measure physical function and symptoms of persons with musculoskeletal disorders of the upper limb. 3 It is a shortened version of the DASH, using 11 items instead of 30. In the breast cancer population, the DASH has shown good outcome measures when testing physical, social and psychological concerns.13,14 The DASH is highly recommended in the breast cancer population and the Quick DASH is also recommended but has not been used as frequently in research.
Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire
时间窗: Up to 2 years
The McGill Pain Questionnaire-Short Form (MPQ-SF). The purpose of the MPQ-SF is to rate qualities and intensities of pain. Fifteen words describe pain and the subject rates the pain words using a 4-point Likert scale. A visual analogue scale is used to identify intensity of pain and symptoms are rated on current and length of pain. The MPQ-SF has been shown to be a valid and reliable tool in the assessment of pain and specifically the assessment of cancer pain.7.8,9 The Breast Edge Task Force Outcomes Committee rated the MPQ-SF as "highly recommend" for use in the breast cancer population.
次要结局
未报告次要终点
研究者
Amy Darragh
Principal Investigator
Ohio State University Comprehensive Cancer Center