Effect of Religious or Spiritual Leaders` Message on Quality of Life of Patients with Breast or Cervical Cancer (Real-QOL): Protocol of Randomized Controlled Trial

Abstract Background Effective psychosocial support involving religious and spiritual leaders has been shown to enhance quality of life and address psychosocial needs during cancer treatment. However, rigorous evidence quantifying the impact of structured religious or spiritual leader delivered interventions on quality of life remains limited in low- and middle-income countries. Therefore, this randomized controlled trial aims to evaluate the effect of structured messages delivered by religious and spiritual leaders on the quality of life of patients with breast or cervical cancer in southern Ethiopia. Methods A total of 112 patients with breast or cervical cancer will be randomized equally into two groups of 56. Both groups will receive an identical educational video containing general cancer information. On Day 1, the intervention group will additionally receive a video message from a religious leader, followed by a face‑to‑face session at Month 3, and a final video session at Month 6. Data will be collected at chemotherapy initiation and at the sixth month after chemotherapy initiation via the KoboToolbox mobile application, utilizing the EORTC QLQ‑C30, FACIT‑Sp‑12, and adherence measures. The primary outcome is patient‑reported quality of life; spirituality and treatment adherence serve as secondary outcomes, analyzed using Analysis of co variance (ANCOVA). Ethical approval was granted by Hawassa University College of Medicine and Health Sciences and Martin Luther University Halle‑Wittenberg. Discussion Our intervention was developed based on existing evidence, and the findings of this study will benefit Ethiopian and African patients, particularly in settings where religious and spiritual considerations have not yet been integrated into medical services. Trial Registration This trial protocol version1.2 was registered at the Pan African Clinical Trial Registry (www.pactr.org) with registration number of PACTR202501810755828.