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Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533663
First Posted: September 21, 2007
Last Update Posted: June 5, 2013
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.
Information provided by (Responsible Party):
Kathy Turner, Stanford University
September 20, 2007
September 21, 2007
June 5, 2013
April 2007
August 2010   (Final data collection date for primary outcome measure)
FACT-B summary score [ Time Frame: Baseline, 6 wks, 14 wks ]
Effect, if any, HT has on quality of life in women undergoing chemotherapy for breast cancer [ Time Frame: During and after treatment ]
Complete list of historical versions of study NCT00533663 on ClinicalTrials.gov Archive Site
Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale [ Time Frame: Baseline, 6 wks, 14 wks ]
  • 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 ]
Not Provided
Not Provided
 
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Early Stage Breast Cancer (Stage 1-3)
  • Procedure: Healing Touch
    every other week (during their infusion)
  • Drug: Standard care
  • Drug: guided relaxation
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2010
August 2010   (Final data collection date for primary outcome measure)

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).

Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00533663
BRSADJ0007
7696 ( Other Identifier: Stanford IRB )
BRSADJ0007
Not Provided
Not Provided
Not Provided
Kathy Turner, Stanford University
Stanford University
Not Provided
Principal Investigator: Dr. Ellie Guardino MD/PhD Stanford University
Principal Investigator: Kathy Turner RN, NP Stanford University
Stanford University
June 2013

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