Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
NCT ID: NCT00574145
Last Updated: 2012-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2007-02-28
2009-04-30
Brief Summary
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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
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
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
fatigue assessment and management
duration
psychosocial assessment and care
duration
quality-of-life assessment
duration
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 cognitive impairment that would preclude the ability to provide informed consent.
* Stage IV breast cancer
* Receiving concurrent chemotherapy and RT
21 Years
75 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Nancy Wells
Research Professor of Nursing; Director, VUMC Nursing
Principal Investigators
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Nancy Wells, DNSc, RN
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Fern Fitzhenry, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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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
Countries
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References
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FitzHenry F, Wells N, Slater V, Dietrich MS, Wisawatapnimit P, Chakravarthy AB. A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy. Integr Cancer Ther. 2014 Mar;13(2):105-13. doi: 10.1177/1534735413503545. Epub 2013 Oct 7.
Other Identifiers
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VU-VICC-SUPP-0633
Identifier Type: -
Identifier Source: secondary_id
VICC SUPP 0633
Identifier Type: -
Identifier Source: org_study_id