title: Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer? A study of factors associated with enrollment among Danish breast cancer patients.
abstract: BACKGROUND
  Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment.
  
  
  METHODS
  We used Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR.
  
  
  RESULTS
  Participants (N = 336) were found to be younger (p < 0.001) and have a less recent diagnosis at invitation than decliners (N = 872; p < 0.001). After adjustment for age and time since diagnosis at invitation, a statistically significant difference was also found between the two groups in use of psychologist sessions (p < 0.05), whereas neither breast cancer variables nor co-morbidity was significantly different. Self-reported data obtained by use of validated psychometric scales from 169 decliners and 336 women who agreed to enroll in the trial showed statistically significant differences in level of education, distress, anxiety, depression, well being and symptom burden. No differences were observed with regard to marital status, children living at home, affiliation to the work market, psychiatric caseness or any lifestyle measure.
  
  
  CONCLUSIONS
  Our findings indicate that participants are younger, have a less recent diagnosis and have a higher level of education than those who refuse. This should be taken into account in designing and evaluating trials of psychosocial interventions and in planning mindfulness-based interventions.
authors.affiliation: Survivorship, Danish Cancer Society Research Center, Copenhagen, Denmark. hannewur@cancer.dk
authors.forename: Hanne
authors.initials: H
authors.lastname: Würtzen
authors.forename: Susanne Oksbjerg
authors.initials: SO
authors.lastname: Dalton
authors.forename: Klaus Kaae
authors.initials: KK
authors.lastname: Andersen
authors.forename: Peter
authors.initials: P
authors.lastname: Elsass
authors.forename: Henrik Lavlund
authors.initials: HL
authors.lastname: Flyger
authors.forename: Antonia
authors.initials: A
authors.lastname: Sumbundu
authors.forename: Christoffer
authors.initials: C
authors.lastname: Johansen
mesh_terms: D001943:Breast Neoplasms / Q000150:complications / Q000523:psychology*; D003718:Denmark; D005260:Female; D006801:Humans; D008875:Middle Aged; D064866:Mindfulness / Q000379:methods; D018579:Patient Selection; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D013315:Stress, Psychological / Q000517:prevention & control*; D016312:Treatment Refusal / Q000523:psychology / Q000706:statistics & numerical data