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

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00440089
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-26
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2010-05-24
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Multiple Fatigue Symptom Inventory

Secondary Outcome Measures

Name	Time	Method
Inflammatory Immune Markers
Diurnal Cortisol Variability

Trial Locations

Locations (2)

General Clinical Research Center, UCSD Medical Center; 🇺🇸 San Diego/Hillcrest, California, United States

Clinical Research Center, UCSD Campus; 🇺🇸 La Jolla, California, United States