NCT00574145

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

Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Depression
• Fatigue

Interventions

Type	Name	Description
PROCEDURE	Bio-field energy therapy	Practitioner's hands to influence the human energy field surrounding the patient's body.
PROCEDURE	fatigue assessment and management	duration
PROCEDURE	psychosocial assessment and care	duration
PROCEDURE	quality-of-life assessment	duration
PROCEDURE	therapeutic touch	Practitioner's hands to influence the human energy field surrounding the patient's body

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-12-17
• Last updated: 2012-09-06
• Results posted: 2012-09-06

Locations

3 sites across 1 country: United States