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

University of California San Diego

Status and phase

Completed

Phase 3

Phase 2

Conditions

Breast Cancer

Treatments

Behavioral: Hands-on-Healing

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00440089

F31AT003021 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment

76 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).