Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00440089
First received: February 23, 2007
Last updated: May 24, 2010
Last verified: November 2009

February 23, 2007
May 24, 2010
October 2005
September 2009   (final data collection date for primary outcome measure)
Multiple Fatigue Symptom Inventory
Same as current
Complete list of historical versions of study NCT00440089 on ClinicalTrials.gov Archive Site
  • Inflammatory Immune Markers
  • Diurnal Cortisol Variability
Same as current
Not Provided
Not Provided
 
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors

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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Breast Cancer
Behavioral: Hands-on-Healing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
September 2009
September 2009   (final data collection date for primary outcome measure)

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).
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440089
F31 AT003021, F31AT003021
Not Provided
Shamini Jain, University of California San Diego
University of California, San Diego
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Shamini Jain, Ph.D. University of California, Los Angeles
Principal Investigator: Paul J Mills, Ph.D. UCSD School of Medicine
University of California, San Diego
November 2009

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