Breast Cancer Clinical Trial
Official title:
Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
Verified date | August 2012 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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