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

Breast Cancer Clinical Trial

Official title:

Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574145
• Other study ID #: VICC SUPP 0633
• Secondary ID: VU-VICC-SUPP-063
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: August 4, 2012
• Start date: February 2007
• Est. completion date: April 2009

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Depression
• Fatigue

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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