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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nancy Wells, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00574145
First received: December 14, 2007
Last updated: August 4, 2012
Last verified: August 2012
December 14, 2007
August 4, 2012
February 2007
April 2009   (Final data collection date for primary outcome measure)
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.
  • Recruitment and retention data
  • Responses to the open-ended questions included in the interview at the end of the study
  • Correlation of demographic data with fatigue as measured by the Brief Fatigue Inventory (BFI) weekly
  • Correlation of demographic data with quality of life as measured by the Functional Assessment of Cancer Therapy-Breast form (FACT-B) at baseline and the end of radiotherapy
  • Correlation of demographic data with anxiety and depression as measure by the Hospital Anxiety and Depression Scale (HAD)
Complete list of historical versions of study NCT00574145 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
Not Provided
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Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Depression
  • Fatigue
  • 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
  • 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
    Interventions:
    • Procedure: Bio-field energy therapy
    • Procedure: fatigue assessment and management
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
    • Procedure: therapeutic touch
  • 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
    Interventions:
    • Procedure: fatigue assessment and management
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2009
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00574145
VICC SUPP 0633
VU-VICC-SUPP-0633
Yes
Not Provided
Not Provided
Not Provided
Nancy Wells, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Nancy Wells, DNSc, RN Vanderbilt-Ingram Cancer Center
Principal Investigator: Fern Fitzhenry, PhD, RN Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP