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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014