Primary and secondary outcome analysis
REGRESSION
The primary outcome measure, HFNS rating scale compared to baseline, will be compared between the CBT intervention + TAU arms at 6 months post randomisation. Difference in HFNS rating scale between the two groups will be analysed using a linear mixed model, adjusting for baseline HFNS rating scale and curative/palliative status. Cohort will be included in the model as a random effect. Interpretation of the effect of the intervention will be based on the regression coefficient for arm and corresponding 95% confidence interval. The difference in HFNS rating scale will also be compared at 6 weeks post randomisation. Secondary outcomes including the frequency of HFNS, the HFNS Beliefs and Behaviour Scale, summary scores of the EORTC QLQ-C30, GAD7, PHQ9, WSAS and PSQI questionnaires at 6 weeks and 6 months post-randomisation will be analysed similarly, accounting for stratification factors and clustering.Analyses will be based on a modified intention-to-treat sample (i.e. excluding participants not contributing data). This will be supported by an analysis that deals with missing data should missingness lead to > 10% of the sample being excluded. Methods may involve either multiple imputation using chained equations or full information maximum likelihood. MANCAN2 will be analysed according to the principles of the International Conference on Harmonisation E9 guidelines and reported using Consolidated Standards of Reporting Trials (CONSORT). A full statistical analysis plan (SAP) will be developed prior to the final analysis.