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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
  Purpose
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.

Condition Intervention
Breast Cancer Early Stage Breast Cancer (Stage 1-3) Procedure: Healing Touch Drug: Standard care Drug: guided relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Kathy Turner, Stanford University:

Primary Outcome Measures:
  • FACT-B summary score [ Time Frame: Baseline, 6 wks, 14 wks ]

Secondary Outcome Measures:
  • Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale [ Time Frame: Baseline, 6 wks, 14 wks ]

Enrollment: 32
Study Start Date: April 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Procedure: Healing Touch
every other week (during their infusion)
Active Comparator: Guided relaxation
Guided relaxation every other week (during their infusion).
Drug: guided relaxation
Active Comparator: standard care
Standard care
Drug: Standard care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
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): NCT00533663


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Ellie Guardino MD/PhD Stanford University
Principal Investigator: Kathy Turner RN, NP Stanford University
  More Information

Responsible Party: Kathy Turner, PI, Stanford University
ClinicalTrials.gov Identifier: NCT00533663     History of Changes
Other Study ID Numbers: BRSADJ0007
7696 ( Other Identifier: Stanford IRB )
First Submitted: September 20, 2007
First Posted: September 21, 2007
Last Update Posted: June 5, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases