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

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

Official Title
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Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Hands-on-Healing


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Hands-on-Healing|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Fatigue Symptom Inventory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Immune Markers |  |  | 
| Diurnal Cortisol Variability |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Fatigue, Breast Cancer, Healing, Energy Healing, Complementary, Alternative, Immune, Cytokine, Hormone, Cortisol, Placebo, Mock Healing