Effects of dignity therapy on dignity and spiritual well-being in people with advanced cancer: study protocol for a randomized controlled trial

Dignity Therapy is a person-centered psychotherapeutic intervention designed for people approaching the end of life, fostering reflection on meaningful aspects of life and creating a testimonial legacy. Since 2011, randomized trials have demonstrated its value in addressing psychospiritual needs and preserving dignity in palliative care. However, no controlled studies have been conducted in Latin America to assess its effectiveness within local cultural contexts. This is a protocol for an exploratory, randomized, parallel-group clinical trial (1:1 allocation) with an open-label design. A total of 96 hospitalized individuals with advanced cancer will participate, all receiving care from the Palliative Care Service of a university hospital in Fortaleza, Brazil. The control group will receive usual palliative care, while the intervention group will receive the same care along with Dignity Therapy, delivered in three structured sessions. Assessments will be conducted at baseline (T1), at the end of the intervention (T2), and short-term follow-up (T3). The primary outcome will be the perceived dignity impact of the intervention, measured by the Dignity Impact Scale. Secondary outcomes will include spiritual well-being, hope, anxiety, depression, and distress. Perceptions of the intervention experience will also be collected from individuals in the intervention group. The primary analysis will be performed using linear mixed models. This trial will provide evidence on the feasibility and potential benefits of Dignity Therapy in supporting dignity and spiritual well-being among individuals with advanced cancer, while also examining how the intervention performs within distinct cultural contexts that may shape perceptions of dignity and end-of-life care. Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-8r3vzw5. Registered on 13 October 2025.