title: Assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for people with advanced cancer referred to a hospital-based palliative care team: Study protocol.
abstract: BACKGROUND
  Loss of dignity for people with advanced cancer is associated with high levels of psychological and spiritual distress and the loss of the will to live. Dignity Therapy is a brief psychotherapy, which has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting in Canada, Australia and the USA, has suggested that Dignity Therapy is beneficial to people with advanced cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in people with advanced cancer who have been referred to hospital-based palliative care teams in the UK, and to pilot the methods for a Phase III RCT.
  
  
  METHODS
  A randomised controlled open-label trial. Forty patients with advanced cancer are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the 'generativity' documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and four weeks after the intervention (equivalent in the control group). The primary outcome is patients' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for patients include distress, hopefulness and quality of life. In view of the relatively small sample size, quantitative analyses are mainly descriptive. The qualitative analysis uses the Framework method.
  
  
  CONCLUSIONS
  Dignity Therapy is brief, can be delivered at the bedside and may help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to patients with advanced cancer, many of whom are likely to be in the terminal stage of their illness, whether it is acceptable to them and their families, if it is likely to be effective, and determine whether a Phase III RCT is desirable.
  
  
  BACKGROUND
  Current Controlled Clinical Trials: ISRCTN29868352.
authors.affiliation: Department of Palliative Care, Policy & Rehabilitation, King's College London, Weston Education Centre, Cutcombe Road, London SE5 9RJ, UK. sue.hall@kcl.ac.uk
authors.forename: Sue
authors.initials: S
authors.lastname: Hall
authors.forename: Polly
authors.initials: P
authors.lastname: Edmonds
authors.forename: Richard
authors.initials: R
authors.lastname: Harding
authors.forename: Harvey
authors.initials: H
authors.lastname: Chochinov
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson