title: BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial.
abstract: OBJECTIVE
  Early breast cancer survivors (BCSs) report high unmet care needs, and easily accessible care is not routinely available for this growing population. The Breast Cancer E-Health (BREATH) trial is a Web-based self-management intervention to support the psychological adjustment of women after primary treatment, by reducing distress and improving empowerment.
  
  
  METHODS
  This multicenter, randomized, controlled, parallel-group trial evaluated whether care as usual (CAU) plus BREATH is superior to CAU alone. BREATH is delivered in sixteen fully automated weekly modules covering early survivorship issues. Two to 4 months post-treatment, BCSs were randomly assigned to receive CAU + BREATH (n = 70) or CAU alone (n = 80) using a stratified block design (ratio 1:1). Primary outcomes were distress (Symptom Checklist-90) and empowerment (Cancer Empowerment Questionnaire), assessed before random assignment (baseline, T0) and after 4 (T1), 6 (T2), and 10 months (T3) of follow-up. Statistical (analysis of covariance) and clinical effects (reliable change index) were tested in an intention-to-treat analysis (T0 to T1). Follow-up effects (T0 to T3) were assessed in assessment completers.
  
  
  RESULTS
  CAU + BREATH participants reported significantly less distress than CAU-alone participants (-7.79; 95% CI, -14.31 to -1.27; P = .02) with a small-to-medium effect size (d = 0.33), but empowerment was not affected (-1.71; 95% CI, 5.20 to -1.79; P = .34). More CAU + BREATH participants (39 of 70 [56%]; 95% CI, 44.1 to 66.8) than CAU-alone participants (32 of 80 [40%]; 95% CI, 30.0 to 51.0) showed clinically significant improvement (P = .03). This clinical effect was most prominent in low-distress BCSs. Secondary outcomes confirmed primary outcomes. There were no between-group differences in primary outcomes during follow-up.
  
  
  CONCLUSIONS
  Access to BREATH reduced distress among BCSs, but this effect was not sustained during follow-up.
authors.affiliation: All authors: Radboud university medical center, Nijmegen, the Netherlands. sanne.vandenberg@radboudumc.nl.
authors.forename: Sanne W
authors.initials: SW
authors.lastname: van den Berg
authors.affiliation: All authors: Radboud university medical center, Nijmegen, the Netherlands.
authors.forename: Marieke F M
authors.initials: MF
authors.lastname: Gielissen
authors.affiliation: All authors: Radboud university medical center, Nijmegen, the Netherlands.
authors.forename: José A E
authors.initials: JA
authors.lastname: Custers
authors.affiliation: All authors: Radboud university medical center, Nijmegen, the Netherlands.
authors.forename: Winette T A
authors.initials: WT
authors.lastname: van der Graaf
authors.affiliation: All authors: Radboud university medical center, Nijmegen, the Netherlands.
authors.forename: Petronella B
authors.initials: PB
authors.lastname: Ottevanger
authors.affiliation: All authors: Radboud university medical center, Nijmegen, the Netherlands.
authors.forename: Judith B
authors.initials: JB
authors.lastname: Prins
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000523:psychology* / Q000628:therapy*; D015928:Cognitive Behavioral Therapy; D000066498:Emotional Adjustment; D005260:Female; D006801:Humans; D020407:Internet; D008875:Middle Aged; D011209:Power, Psychological; D012648:Self Care; D057566:Self Report; D013315:Stress, Psychological / Q000209:etiology / Q000517:prevention & control*; D017741:Survivors / Q000523:psychology; D016896:Treatment Outcome