Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Fatigue Using the Brief Fatigue Inventory (BFI)
研究概览
简要总结
RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast cancer who are undergoing radiation therapy.
PURPOSE: This randomized clinical trial is studying how well healing touch works in treating fatigue in women undergoing radiation therapy for breast cancer.
详细描述
OBJECTIVES:
- To determine the ability to recruit and retain patients with breast cancer receiving curative radiotherapy in a Complementary and Alternative Medicine trial.
- To determine the acceptability of weekly healing touch therapy to patients with breast cancer who receive curative radiotherapy.
- To examine the effect of healing touch on fatigue and quality of life for patients with breast cancer receiving radiotherapy as a component of therapy.
OUTLINE: Patients are stratified by type of treatment (radiotherapy alone vs chemotherapy completed prior to radiotherapy)
- Arm I:Patients receive healing-touch therapy administered once a week for 45 minutes by a healing-touch therapist for the duration of radiotherapy.
- Arm II: Patients receive sham-therapy administered once a week for 45 minutes by a sham-practitioner (NOT a healing-touch therapist) for the duration of radiotherapy.
Patients complete the Hospital Anxiety and Depression Scale (HAD) and a demographic variables form (age, race/ethnicity, marital status, employment) at baseline. Patient fatigue is measured on a weekly basis throughout radiotherapy with completion of the Brief Fatigue Inventory (BFI). The Functional Assessment of Cancer Therapy-Breast form (FACT-B) is completed at baseline and the end of radiotherapy. Patients undergo a 20-minute interview at the end of study to determine the acceptability 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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven breast cancer
- •Receiving post lumpectomy or post mastectomy radiation therapy (RT)
- •Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- •Prescribed a minimum of 5 weeks of RT
- •Between the ages of 21 and 75
- •Able to speak English.
- •Provides written informed consent
排除标准
- •Documented active psychiatric illness
- •Documented cognitive impairment that would preclude the ability to provide informed consent.
- •Stage IV breast cancer
- •Receiving concurrent chemotherapy and RT
结局指标
主要结局
Fatigue Using the Brief Fatigue Inventory (BFI)
时间窗: 6 weeks
9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.
次要结局
- Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)(baseline and 6 weeks)
- Intensity of Anxiety and Depression(baseline and off-radiation at 5 to 7 weeks)
研究者
Nancy Wells
Research Professor of Nursing; Director, VUMC Nursing
Vanderbilt-Ingram Cancer Center