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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Multiple Fatigue Symptom Inventory

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

Enrollment: 76
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (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
Clinical Research Center, UCSD Campus
La Jolla, California, United States, 92037
General Clinical Research Center, UCSD Medical Center
San Diego/Hillcrest, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Shamini Jain, Ph.D. University of California, Los Angeles
Principal Investigator: Paul J Mills, Ph.D. UCSD School of Medicine
  More Information

No publications provided

Responsible Party: Shamini Jain, University of California San Diego
ClinicalTrials.gov Identifier: NCT00440089     History of Changes
Other Study ID Numbers: F31 AT003021, F31AT003021
Study First Received: February 23, 2007
Last Updated: May 24, 2010
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
Cancer
Fatigue
Breast Cancer
Healing
Energy Healing
Complementary
Alternative
Immune
Cytokine
Hormone
Cortisol
Placebo
Mock Healing

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

ClinicalTrials.gov processed this record on April 23, 2014