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
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: 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 August 28, 2014