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Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
This study has been completed.
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00440089
  Purpose

This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and immune function in breast cancer survivors. Participants may be randomized to one of three groups: hands-on-healing, touch alone, or a control group.


Condition Intervention Phase
Breast Cancer
Behavioral: Hands-on-Healing
Phase II
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Multiple Fatigue Symptom Inventory

Secondary Outcome Measures:
  • Inflammatory Immune Markers
  • Diurnal Cortisol Variability

Estimated Enrollment: 60
Study Start Date: October 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Please see our website at http://healing.ucsd.edu for detailed information on the study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal and postmenopausal women between the ages of 18 to 70 years.
  • Ability to give informed consent.
  • Breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. We have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
  • Stage I to III breast cancer survivors.
  • Breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
  • Breast cancer survivors with above-normative levels of fatigue.

Exclusion Criteria:

  • Breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
  • Patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
  • Patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
  • Patients with other inflammatory diseases that affect cytokine levels.
  • Patients with a history of other cancers, and stage IV breast cancer.
  • Patients undergoing current chemotherapy and/or radiotherapy.
  • Men with breast cancer.
  • Substance abuse/dependence.
  • Continued use of another biofield-based intervention (e.g., Reiki, Qi-Gong, Healing Touch, Therapeutic Touch, Johrei).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440089

Locations
United States, California
General Clinical Research Center, UCSD Medical Center
San Diego/Hillcrest, California, United States, 92103
Clinical Research Center, UCSD Campus
La Jolla, California, United States, 92037
Sponsors and Collaborators
Investigators
Principal Investigator: Shamini Jain, M.A., M.S. SDSU/UCSD Joint Doctoral Program, Clinical Psychology
Study Chair: Paul J Mills, Ph.D. UCSD School of Medicine
  More Information

Study website  This link exits the ClinicalTrials.gov site

Responsible Party: University of California San Diego ( Shamini Jain )
Study ID Numbers: F31 AT003021
Study First Received: February 23, 2007
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00440089  
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Cancer
Fatigue
Breast Cancer
Healing
Energy Healing
Complementary
Alternative
Immune
Cytokine
Hormone
Cortisol
Placebo
Mock Healing

Study placed in the following topic categories:
Hydrocortisone
Fatigue
Cortisol succinate
Skin Diseases
Breast Neoplasms
Hydrocortisone acetate
Breast Diseases
Inflammation

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009