JMIR Publications

ABSTRACT

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. Clinical Trial: ACTRN12620000902998