Assessing the Impact of an Online Intervention (Nuts & Bolts) on Men with Newly Diagnosed Testicular Cancer using a Mixed Methods Approach

BACKGROUND: Distress is common following a new testicular cancer (TC) diagnosis. Existing research and resources largely focus on long‐term survivors. Nuts & Bolts has been designed by the Movember Foundation® to address this unmet need. We conducted a prospective, randomised controlled trial evaluating the impact of Nuts & Bolts on distress. METHODS: Adults diagnosed with TC (within four weeks) were randomly assigned (1:1) to access to Nuts & Bolts at consent ('early intervention'), or 8 days later ('delayed intervention'). The primary endpoint was change in distress, measured by the National Comprehensive Cancer Network Distress Thermometer (DT; score range 0‐10), from baseline to day 8. Secondary endpoints of distress, anxiety and depression were assessed using DT and Hospital Anxiety and Depression Scale (HADS) at defined intervals across four weeks. Semi‐structured interviews conducted after four weeks were thematically analysed. RESULTS: 39 patients diagnosed a median of 15 days earlier were randomised to 'early' (n=20) or 'delayed' (n=19) groups. Early intervention did not indicate significant decrease in mean DT score by day 8 (early: ‐1.9 versus delayed: ‐1.7, p=0.85). However, a reduction in distress was observed in both groups across one (early: p<0.0001; delayed: p<0.01) and four weeks (early: p<0.001; delayed: p=0.01) following intervention. Thematic analysis from semi‐structured interviews revealed four key themes, including the helpfulness of the intervention across the TC journey. Nuts & Bolts was considered highly useful and early access was seen as key to maximising benefit. CONCLUSIONS: High levels of distress are common in men with newly diagnosed TC; however, this reduces over 1‐4 weeks. While earlier introduction to Nuts & Bolts did not impact change in distress across oneweek, this may have been due to the timing of its implementation following diagnosis. Nuts & Bolts was considered highly useful, acceptable, and relevant by men diagnosed with TC.