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

BACKGROUND Distress is common immediately following a diagnosis with testicular cancer, however there is an unmet need to develop instruments to address this important issue. OBJECTIVE We evaluated an online intervention, Nuts & Bolts, designed to provide support and alleviate distress associated with the diagnosis of testicular cancer in individuals with a new diagnosis. METHODS In this trial using a mixed methods design designed to evaluate the acceptability, feasibility and impact of Nuts & Bolts, we randomly assigned 39 participants with recently diagnosed testicular cancer in a 1:1 ratio to access Nuts & Bolts at the time of consent (“early”), or alternatively, one week later (day 8; “delayed”). The primary endpoint was change in distress, measured by the National Comprehensive Cancer Network Distress Thermometer (DT; score range 0-10), between consent/day 8. Secondary endpoints of distress, anxiety and depression were assessed at defined intervals across a four-week follow-up period; semi-structured interviews were thematically analysed. RESULTS Moderate- or high-levels of distress evaluated using DT were reported in 58% of participants at the time of consent. “Early intervention” with Nuts & Bolts did not significantly decrease mean DT score by day eight compared to “delayed intervention” (early: 4.56 to 2.74 versus delayed: 4.47 to 2.74, p=.85), however reduced DT scores were observed by day 8 (early: p<.001; delayed: p=.012) regardless of the timing of the intervention. A significant reduction in DT scores was observed four-weeks following the intervention in the early (p<.001) and delayed intervention group (p=.010). Thematic analysis of 18 semi-structured interviews revealed four key themes, including pertinently, the helpfulness of the intervention across the journey. Nuts & Bolts was considered useful, relevant and ‘easy to use’ by most participants, however early access was key to maximising benefit and ameliorating the ‘whirlwind’ of diagnosis and treatment. CONCLUSIONS Distress is common following diagnosis with testicular cancer; however, reduces over time. Earlier introduction to Nuts & Bolts did not impact change in distress across one-week measured by DT, but utility was widely supported by participants. Nuts & Bolts was considered useful, acceptable, and relevant by individuals diagnosed with testicular cancer. It may have a greater impact on distress if utilised as soon as testicular cancer is suspected. CLINICALTRIAL ACTRN12620000902998