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

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ClinicalTrials.gov Identifier: NCT00574145
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nancy Wells, Vanderbilt-Ingram Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Depression Fatigue Procedure: Bio-field energy therapy Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: therapeutic touch Not Applicable

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
Study Start Date : February 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


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
Procedure: Bio-field energy therapy
Practitioner's hands to influence the human energy field surrounding the patient's body.
Other Name: biofield therapy

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

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
Procedure: fatigue assessment and management
duration

Procedure: psychosocial assessment and care
duration

Procedure: quality-of-life assessment
duration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574145


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nancy Wells, DNSc, RN Vanderbilt-Ingram Cancer Center
Principal Investigator: Fern Fitzhenry, PhD, RN Vanderbilt-Ingram Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Wells, Research Professor of Nursing; Director, VUMC Nursing, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00574145     History of Changes
Other Study ID Numbers: VICC SUPP 0633
VU-VICC-SUPP-0633
First Posted: December 17, 2007    Key Record Dates
Results First Posted: September 6, 2012
Last Update Posted: September 6, 2012
Last Verified: August 2012

Keywords provided by Nancy Wells, Vanderbilt-Ingram Cancer Center:
fatigue
depression
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Signs and Symptoms