title: Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial.
abstract: BACKGROUND
  Fatigue is a chief complaint in cancer patients, and warrants effective treatment. Biofield therapies are complementary medicine approaches used by cancer populations. There is little information about their efficacy.
  
  
  METHODS
  This blinded, randomized controlled trial examined the effects of 4 weeks (eight 1-hour sessions) of biofield healing compared with mock healing and a waitlist control group on fatigue in 76 fatigued breast cancer survivors (stages I-IIIa). Secondary outcomes were diurnal cortisol variability (via estimates of cortisol slope), depression, and quality of life (QOL). Treatment belief was assessed to explore whether belief predicted outcomes. Data were analyzed via hierarchical linear modeling.
  
  
  RESULTS
  There were no significant differences between biofield healing and mock healing on belief; 75% thought they received biofield healing. Compared with controls, biofield healing significantly decreased total fatigue (P < .0005, Cohen's d = 1.04), as did mock healing (P = .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 < .04 in both cases; Cohen's d = 0.58). Belief predicted changes in QOL over and above group (P = .004, Cohen's d = 0.84). Belief did not impact fatigue or cortisol variability.
  
  
  CONCLUSIONS
  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. There is a need to further examine the effects of specific processes of biofield healing on outcomes for cancer populations.
authors.affiliation: Samueli Institute, Alexandria, Virginia, USA. sjain@samueliinstitute.org
authors.forename: Shamini
authors.initials: S
authors.lastname: Jain
authors.forename: Desiree
authors.initials: D
authors.lastname: Pavlik
authors.forename: Janet
authors.initials: J
authors.lastname: Distefan
authors.forename: Rosalyn L
authors.initials: RL
authors.lastname: Bruyere
authors.forename: Julia
authors.initials: J
authors.lastname: Acer
authors.forename: Rosalie
authors.initials: R
authors.lastname: Garcia
authors.forename: Ian
authors.initials: I
authors.lastname: Coulter
authors.forename: John
authors.initials: J
authors.lastname: Ives
authors.forename: Scott C
authors.initials: SC
authors.lastname: Roesch
authors.forename: Wayne
authors.initials: W
authors.lastname: Jonas
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Mills
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000150:complications / Q000628:therapy*; D016022:Case-Control Studies; D000529:Complementary Therapies; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism*; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life; D015996:Survival Rate; D017741:Survivors
chemical_list: D006854:Hydrocortisone