title: Protocol for the RT Prepare Trial: a multiple-baseline study of radiation therapists delivering education and support to women with breast cancer who are referred for radiotherapy.
abstract: BACKGROUND
  There is limited evidence to guide the preparation of patients for radiotherapy. This paper describes the protocol for an evaluation of a radiation therapist led education intervention delivered to patients with breast cancer in order to reduce psychological distress.
  
  
  METHODS
  A multiple-baseline study is being used. Usual care data is being collected prior to the start of the intervention at each of three sites. The intervention is delivered by radiation therapists consulting with patients prior to their treatment planning and on the first day of treatment. The intervention focuses on providing sensory and procedural information to patients and reducing pretreatment anxiety. Recruitment is occurring in three states in Australia. Eligible participants are patients who have been referred for radiotherapy to treat breast cancer. 200 patients will be recruited during a usual care phase and, thereafter, 200 patients in the intervention phase. Measures will be collected on four occasions-after meeting with their radiation oncologist, prior to treatment planning, on the first day of treatment and after treatment completion. The primary hypothesis is that patients who receive the radiotherapy preparatory intervention will report a significantly greater decrease in psychological distress from baseline to prior to radiotherapy treatment planning in comparison with the usual care group. Secondary outcome measures include concerns about radiotherapy, patient knowledge of radiotherapy, patient preparedness and quality of life. Patient health system usage and costs will also be measured. Multilevel mixed effects regression models will be applied to test for intervention effects.
  
  
  METHODS
  Ethics approval has been gained from Curtin University and the three recruiting sites.
  
  
  RESULTS
  Results will be reported in international peer reviewed journals.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registration: ACTRN12611001000998.
authors.affiliation: School of Nursing and Midwifery, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
authors.forename: Georgia
authors.initials: G
authors.lastname: Halkett
authors.affiliation: School of Psychology and Speech Pathology, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
authors.forename: Moira
authors.initials: M
authors.lastname: O'Connor
authors.affiliation: Cancer Services and Information, Cancer Institute NSW, Sydney, New South Wales, Australia Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia Sir Peter MacCallum Department of Oncology and Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Sanchia
authors.initials: S
authors.lastname: Aranda
authors.affiliation: Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia Sir Peter MacCallum Department of Oncology and Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Jefford
authors.affiliation: Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Department of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Nigel
authors.initials: N
authors.lastname: Spry
authors.affiliation: School of Exercise and Health Science, Edith Cowan University, Perth, Western Australia, Australia.
authors.forename: Therese
authors.initials: T
authors.lastname: Shaw
authors.affiliation: Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
authors.forename: Rachael
authors.initials: R
authors.lastname: Moorin
authors.affiliation: Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia Sir Peter MacCallum Department of Oncology and Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Penelope
authors.initials: P
authors.lastname: Schofield
mesh_terms: D001943:Breast Neoplasms / Q000523:psychology* / Q000532:radiotherapy; D005260:Female; D006282:Health Personnel; D006801:Humans; D010353:Patient Education as Topic; D018787:Radiation Oncology; D012017:Referral and Consultation; D012107:Research Design; D012944:Social Support; D013315:Stress, Psychological / Q000517:prevention & control*
keywords: HEALTH ECONOMICS; MEDICAL EDUCATION & TRAINING