Enhancing men's awareness of testicular diseases (E-MAT) feasibility trial: Protocol for a mixed method process evaluation.
Josephine HegartyMegan McCarthyMartin DavorenFrances ShielyJanas M HarringtonGillian W ShorterDavid MurphyEoghan CookeBilly O'MahonyMohamad M SaabPublished in: HRB open research (2022)
Background : Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes are particularly at risk of testicular trauma and diseases. Experiencing negative testicular symptoms does not necessarily imply that men seek help. Men's awareness of testicular diseases is often lacking and their intention to seek help for testicular symptoms is sub-optimal. The use of virtual reality (VR) may be effective in promoting men's awareness of testicular diseases. The Enhancing Men's Awareness of Testicular diseases (E-MAT) feasibility trial aims to test the effect of E-MAT VR (intervention; interactive experience using virtual reality [VR]) compared to information delivered Electronically E-MAT E (control; same information as E-MAT VR delivered as plain text and images) on testicular knowledge, and testicular self-examination among male athletes affiliated with a national sports organisation. The overall aim of this mixed method process evaluation will be to describe (i) the experiences of participants and key stakeholders (e.g., researchers); (ii) the perceived effectiveness of intervention components; (iii) acceptability of the feasibility trial and intervention procedures; (iv) the relationship between implementation, mechanisms, and context; and (v) the barriers and facilitators to support effective conduct of a future definitive trial. Methods: This mixed method process evaluation will use a descriptive realist evaluation. Quantitative data will be gathered using a usability and satisfaction survey, in addition to fidelity checks during intervention delivery. Quantitative data will be analysed using descriptive and inferential statistics. Qualitative data will be gathered from semi-structured interviews and focus groups with participants and key stakeholders to investigate their experiences of E-MAT VR and E-MAT E , and explore areas for improvement. Thematic analysis of transcripts will be conducted. Conclusions: This process evaluation will provide an in-depth understanding of how the interventions worked within this cohort and lessons for a future definitive trial.
Keyphrases
- virtual reality
- germ cell
- randomized controlled trial
- study protocol
- phase iii
- clinical trial
- phase ii
- electronic health record
- middle aged
- mental health
- healthcare
- physical activity
- big data
- cross sectional
- high resolution
- primary care
- systematic review
- squamous cell carcinoma
- optical coherence tomography
- current status
- artificial intelligence
- machine learning
- social support
- open label
- convolutional neural network
- double blind
- mass spectrometry
- clinical evaluation
- sleep quality