Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Enrollment
- 44
- Locations
- 3
- Primary Endpoint
- Fatigue Using the Brief Fatigue Inventory (BFI)
- Status
- Completed
- Last Updated
- 13 years ago
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.
Investigators
Nancy Wells
Research Professor of Nursing; Director, VUMC Nursing
Vanderbilt-Ingram Cancer Center
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
Outcomes
Primary Outcomes
Fatigue Using the Brief Fatigue Inventory (BFI)
Time Frame: 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.
Secondary Outcomes
- 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)