EXPLORING THE COMPLEXITY OF MENTAL HEALTH OUTCOMES: A REALIST EVALUATION OF QUALITATIVE INTERVIEWS WITH PROSTATE CANCER PATIENTS IN THE PHASE 3 RANDOMIZED CLINICAL TRIAL OF THE PROSTATE CANCER-PATIENT EMPOWERMENT PROGRAM (PC-PEP)

Abstract

This thesis presents a realist evaluation of the Prostate Cancer-Patient Empowerment Program (PC-PEP), examining the contextual factors and mechanisms influencing mental health outcomes among participants in the Phase 3 PC-PEP Randomized Clinical Trial (RCT). The study investigates what patient-related contexts and mechanisms explain differences in mental health outcomes between intervention (early) and control (delayed) groups at six months post-randomization. Out of 128 men in the full RCT, 43 participants (33%), 25 from the early intervention group and 18 from the delayed group, participated in semi-structured qualitative interviews. Key findings highlight individual psychological contexts, partner and family involvement, employment status, cultural beliefs, social support, the COVID-19 pandemic, early intervention, and the involvement of clinical experts. These findings suggest that integrating psychosocial support programs like PC-PEP into standard prostate cancer care, particularly early in the treatment process, can significantly enhance mental health outcomes.