Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
研究概览
简要总结
Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.
详细描述
The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform.
Primary Objectives:
- . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
- To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
- To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT.
Secondary Objectives:
- To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
- To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
- •Age > 18 years
- •ECOG performance score < 3
- •English-speaking
- •with sufficient vision/hearing or family support
- •Coronary artery disease, if cleared by cardiologist
- •Subject must have smart phone, computer or tablet.
- •Willingness to be randomized
排除标准
- •Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).
- •Patients with overt evidence of a psychiatric disorder.
- •Coronary artery disease, not cleared by cardiologist.
- •Contraindication to exercise.
- •Chronic fatigue syndrome.
研究组 & 干预措施
Exercise
Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.
干预措施: Exercise (Behavioral)
Control
Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.
结局指标
主要结局
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
时间窗: Month 6 following completion of chemotherapy
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
时间窗: Baseline
The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
时间窗: Weekly for 12 weeks
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
时间窗: Month 1 following completion of chemotherapy
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
时间窗: Month 3 following completion of chemotherapy
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
次要结局
- To quantify the change over time in PRO-CTCAE derived symptoms(Month 6 following completion of chemotherapy)
- To quantify the change over time in PRO-CTCAE derived symptoms(Month 1 following completion of chemotherapy)
- To quantify the change over time in PRO-CTCAE derived symptoms(Baseline)
- To quantify the change over time in PRO-CTCAE derived symptoms(Weekly for 12 weeks)
- To quantify the change over time in PRO-CTCAE derived symptoms(Month 3 following completion of chemotherapy)