Breast Cancer
Conditions
Keywords
Cancer, Fatigue, Breast Cancer, Healing, Energy Healing, Complementary, Alternative, Immune, Cytokine, Hormone, Cortisol, Placebo, Mock Healing
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.
Interventions
BEHAVIORALHands-on-Healing
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple Fatigue Symptom Inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory Immune Markers | — |
| Diurnal Cortisol Variability | — |
Countries
United States
Outcome results
None listed