Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue

Conditions
-----------------
Breast Cancer, Depression, Fatigue

Intervention / Treatment
-----------------
* Procedure: Bio-field energy therapy
* Procedure: fatigue assessment and management
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment
* Procedure: therapeutic touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy/Supportive Care (A)<br>Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy | Procedure: Bio-field energy therapy<br>* Practitioner's hands to influence the human energy field surrounding the patient's body.<br>* Other names: biofield therapy;Procedure: fatigue assessment and management<br>* duration<br>Procedure: psychosocial assessment and care<br>* duration<br>Procedure: quality-of-life assessment<br>* duration<br>Procedure: therapeutic touch<br>* Practitioner's hands to influence the human energy field surrounding the patient's body<br>|
| Sham Comparator: Control ARM (B)<br>Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy | Procedure: fatigue assessment and management<br>* duration<br>Procedure: psychosocial assessment and care<br>* duration<br>Procedure: quality-of-life assessment<br>* duration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Using the Brief Fatigue Inventory (BFI) | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | 36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined | baseline and 6 weeks | 
| Intensity of Anxiety and Depression | Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints. | baseline and off-radiation at 5 to 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatigue, depression, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer