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Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00533663
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Kathy Turner, Stanford University

Tracking Information
First Submitted Date  ICMJE September 20, 2007
First Posted Date  ICMJE September 21, 2007
Last Update Posted Date June 5, 2013
Study Start Date  ICMJE April 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
FACT-B summary score [ Time Frame: Baseline, 6 wks, 14 wks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
Effect, if any, HT has on quality of life in women undergoing chemotherapy for breast cancer [ Time Frame: During and after treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale [ Time Frame: Baseline, 6 wks, 14 wks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
  • Effect, if any, HT has on anxiety, depression, nausea and fatigue in women undergoing chemotherapy for breast cancer [ Time Frame: During and after treatment ]
  • Feasibility of delivering HT at the bedside in the Infusion Center [ Time Frame: During treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
Official Title  ICMJE Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
Brief Summary To study the effectiveness of Healing Touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Early Stage Breast Cancer (Stage 1-3)
Intervention  ICMJE
  • Procedure: Healing Touch
    every other week (during their infusion)
  • Drug: Standard care
  • Drug: guided relaxation
Study Arms  ICMJE
  • Experimental: Healing Touch (HT)
    A a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy. It occurs every other week (during their infusion).
    Intervention: Procedure: Healing Touch
  • Active Comparator: Guided relaxation
    Guided relaxation every other week (during their infusion).
    Intervention: Drug: guided relaxation
  • Active Comparator: standard care
    Standard care
    Intervention: Drug: Standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2013)
32
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2007)
45
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:- Stage I or II breast cancer

  • Post-op
  • On treatment protocol of eight weeks of AC given every other week followed by 8 weeks of paclitaxel given every other week
  • ECOG Performance Status: 0-2
  • Speak and read English Exclusion Criteria:- Previous chemotherapy exposure
  • Concomitant energy work interventions (HT, Reiki, QiGong, acupuncture).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00533663
Other Study ID Numbers  ICMJE BRSADJ0007
7696 ( Other Identifier: Stanford IRB )
BRSADJ0007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathy Turner, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Ellie Guardino MD/PhD Stanford University
Principal Investigator: Kathy Turner RN, NP Stanford University
PRS Account Stanford University
Verification Date June 2013

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