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Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
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.
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.
Age
21 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
February 1, 2007
Primary Completion Date
April 1, 2009
Completion Date
April 1, 2009
Last Updated
September 6, 2012
44
ACTUAL participants
Bio-field energy therapy
PROCEDURE
fatigue assessment and management
PROCEDURE
psychosocial assessment and care
PROCEDURE
quality-of-life assessment
PROCEDURE
therapeutic touch
PROCEDURE
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT04550494
NCT05673200
Data Source & Attribution
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