Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
August 4, 2012 updated by: Nancy Wells, Vanderbilt-Ingram Cancer Center
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Radiotherapy/Supportive Care (A)
Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
|
Practitioner's hands to influence the human energy field surrounding the patient's body.
Other Names:
duration
duration
duration
Practitioner's hands to influence the human energy field surrounding the patient's body
|
|
Sham Comparator: Control ARM (B)
Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy
|
duration
duration
duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)
Time Frame: baseline and 6 weeks
|
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
|
|
Intensity of Anxiety and Depression
Time Frame: baseline and off-radiation at 5 to 7 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Fern Fitzhenry, PhD, RN, Vanderbilt-Ingram Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Estimate)
September 6, 2012
Last Update Submitted That Met QC Criteria
August 4, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC SUPP 0633
- VU-VICC-SUPP-0633
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.