Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
21 Years
75 Years
Female
Breast Cancer, Depression, Fatigue
Trial Information
Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Fatigue Using the Brief Fatigue Inventory (BFI)
Outcome Description:
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.
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Nancy Wells, DNSc, RN
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
VICC SUPP 0633
NCT ID:
NCT00574145
Start Date:
February 2007
Completion Date:
April 2009
Related Keywords:
- Breast Cancer
- Depression
- Fatigue
- 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
- Breast Neoplasms
- Depression
- Depressive Disorder
- Fatigue
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |
