Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue

Vanderbilt-Ingram Cancer Center3 个研究点分布在 1 个国家目标入组 44 人开始时间: 2007年2月1日最近更新: 2012年9月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Vanderbilt-Ingram Cancer Center
入组人数: 44
试验地点: 3
主要终点: Fatigue Using the Brief Fatigue Inventory (BFI)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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