Implementation and Evaluation of a Culturally-Appropriate Protocol for Breaking Bad News to Patients With Cancer in Iran: Study Protocol for a Complex Mixed Methods Experimental Study

Awareness of disease diagnosis is one the most basic steps to treatment onset and adherence among patients with cancer (PWC). However, PWC are not accurately informed about their diagnosis and hence, cannot accurately understand treatment options and improve treatment outcomes. This study will evaluate the effects of a culturally-appropriate breaking bad news protocol (BBNP) on PWC in Iran. It will be conducted using a complex mixed methods experimental design and in two quantitative and qualitative phases. In the quantitative phase, a randomized controlled trial will be undertaken to assess the effects of BBNP on depression, anxiety, stress, and life expectancy. Data collection instruments will be the Depression Anxiety Stress Scale and the Adult Hope Scale. In the qualitative phase, a qualitative study will be undertaken using conventional content analysis in order to explore patients’ experiences of breaking bad news. The use of culturally-appropriate and evidence-based breaking bad news guidelines and interventions can improve patient outcomes and protect patient dignity. Trial registry name: Iranian Registry of Clinical Trials (Number: IRCT20240118060721N1).