Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathy Turner, Stanford University
ClinicalTrials.gov Identifier:
NCT00533663
First received: September 20, 2007
Last updated: June 3, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 Stanford University:

Primary Outcome Measures:
  • FACT-B summary score [ Time Frame: Baseline, 6 wks, 14 wks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kathy Turner, PI, Stanford University
ClinicalTrials.gov Identifier: NCT00533663     History of Changes
Other Study ID Numbers: BRSADJ0007, 7696, BRSADJ0007
Study First Received: September 20, 2007
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014