Jain, S., Pavlik, D., Distefan, J., Bruyere, R. L., Acer, J., Garcia, R., . . . Mills, P. J. (2012). Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial. Cancer, 118, 777–787.

To examine, within a blinded, randomized, controlled trial design, whether biofield therapy (hands-on healing) would significantly reduce fatigue in survivors with persistent cancer-related fatigue compared to mock healing and a wait-list control group.   

Energy chelation (hands-on-healing with standard hand positions focusing for five to seven minutes over each body part, i.e., feet, hips, knees, bladder, stomach, hands, elbows, shoulders, heart, throat, head, and heart) for one hour, two times each week for four weeks in the intervention group; mock biofield therapy for one hour, two times each week for four weeks; and a wait-list with no specific intervention. All participants submitted saliva samples at four time points. Timing of self-reported measures of quality of life (QOL) and depression were not reported.

• In total, 76 participants (100% female) with breast cancer were included. 
• Age ranged from 31 to 75 years. Mean age was 52 years in the healing group, 52 years in the mock group, and 50 years in the wait-list control group.
• Patients were included if they
  • Were aged 18 to 70 years
  • Were stage I to IIIA
  • Were one month to 10 years post completion of adjuvant or neoadjuvant therapy
  • Scored less than 50 on the RAND SF-36 vigor-fatigue subscale
  • Had no current use of biofield therapy.

• Single site  
• Outpatient
• University of San Diego, San Diego, California

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for late effects and survivorship.

The study used a blinded, randomized, controlled design.

• RAND SF-36 vigor-fatigue subscale    
• Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
• Center for Epidemiologic Studies Depression (CESD) Scale
• Functional Assessment of Cancer Therapy-Breast (FACT-B)
• Biofield Therapies Use and Expectations Questionnaire
   

• Overall attrition was 9%, with no differential attrition between groups. 
• No adverse events were reported.
• Previous use of biofield therapy was 49% prior to the study.
• The passage of time predicted changes for the overall sample for fatigue and QOL but not depression.
• There were no significant differences between biofield healing and mock healing on belief.
• Of the participants, 75% thought they received biofield healing.
• Compared with controls, biofield healing significantly decreased total fatigue (p < 0.0005; Cohen's d = 1.04), as did mock healing (p = 0.02; Cohen's d = 0.68), with no significant differences between biofield healing and mock healing.
• Cortisol slope significantly decreased for biofield healing versus both mock healing and control (p < 0.04 for both; Cohen's d = 0.58).
• Belief predicted changes in QOL over and above group (p = 0.004; Cohen's d = 0.84).
• Belief did not affect fatigue or cortisol variability.

Nonspecific factors are important in responses to biofield interventions for fatigue. Belief predicts QOL responses but not fatigue or cortisol variability. Biofield therapies increase cortisol variability independent of belief and other nonspecific factors. A need exists to further examine the effects of specific processes of biofield healing on outcomes for cancer populations.

• The study had a small sample size, with less than 100 participants.
• The study lacked follow-up assessment.
• The study lacked generalizability.
• Participants older than 70 years of age were included, which was determined to be an exclusion criterion.
   

Use of a hands-on healing intervention takes time and a skill set not traditionally taught in undergraduate or graduate nursing programs. Few clinical nurses have the time or skills to practice hands-on healing as described in the study. The intervention is noninvasive and a potentially effective independent nursing intervention with a minimal side effect profile.