title: Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial.
abstract: BACKGROUND
  There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.
  
  
  METHODS
  Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.
  
  
  RESULTS
  Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval -15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.
  
  
  CONCLUSIONS
  Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.
  
  
  BACKGROUND
  ISRCTN29666484.
authors.affiliation: Cancer Care Research Centre, School of Nursing, Midwifery and Health, University of Stirling, Highland Campus, Centre for Health Science, Old Perth Road, Inverness IV2 3JH, UK. gill.hubbard@stir.ac.uk
authors.forename: Gill
authors.initials: G
authors.lastname: Hubbard
authors.forename: Nicola M
authors.initials: NM
authors.lastname: Gray
authors.forename: Dolapo
authors.initials: D
authors.lastname: Ayansina
authors.forename: Josie M M
authors.initials: JM
authors.lastname: Evans
authors.forename: Richard G
authors.initials: RG
authors.lastname: Kyle
mesh_terms: D000041:Absenteeism; D000293:Adolescent; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000601:surgery*; D019090:Case Management; D004608:Eligibility Determination; D005221:Fatigue / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008408:Mastectomy / Q000009:adverse effects / Q000534:rehabilitation*; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D012050:Rehabilitation, Vocational; D012107:Research Design; D062707:Return to Work; D012606:Scotland; D018582:Sick Leave; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult