A novel approach to enhancing hope in patients with advanced cancer: a randomised phase II trial of dignity therapy

MAIN OBJECTIVE: To assess the ability of dignity therapy to reduce distress in advanced cancer patients.; DESIGN: A phase II open-label trial.; SETTING: Two UK National Health Service trusts.; PARTICIPANTS: 45 adults with advanced cancer.; INTERVENTION: Dignity therapy: a brief palliative care psychotherapy.; METHODS: Participants were randomly allocated to receive the intervention plus standard care or standard care only (control group). Outcomes were collected at baseline and at 1- and 4-week follow-up.; MAIN OUTCOME MEASURES: The primary outcome was dignity-related distress (Palliative Dignity Inventory). Secondary outcomes were hope, anxiety and depression, quality of life, palliative-related outcomes, and self-reported study benefits.; RESULTS: 45/188 (24%) patients responded. 27/45 (60%) participants remained at 1-week and 20/45 (44%) at 4-week follow-up. Baseline levels of distress were low. Groups did not differ in dignity-related distress at any time. An effect on only one secondary outcome was found: the intervention group reported more hope than the control group at both follow-ups. Effect sizes were medium (partial η(2)=0.20 and 0.15) and the difference was statistically significant at 1-week follow-up (difference in adjusted means 2.55; 95% CI -4.73 to 0.36; p=0.02). The intervention group was more positive than the control group on all the self-reported benefits ratings. Effect sizes (Cohen's d) ranged from 1.34 for feeling that dignity therapy had helped to 0.31 for increasing will to live.; CONCLUSIONS: The effects of dignity therapy on people with advanced cancer are encouraging. Further investigation is warranted focusing on distressed patients and those earlier in the palliative care trajectory.; TRIAL REGISTER NUMBER: ISRCTN29868352.