Study flow chart and demographics and patient characteristics

Number of patients included and excluded from the respective emulated trials.

Trial 1 and 2 will not be analysed due to too few in the Active group.

Q: What to present in demography table?

Statistical model

Endpoints modelled using ordinal regression assuming proportional odds. Weakly regularizing priors (\(\beta \sim N(0, 1)\)) on the logit scale were used for treatment factor (Active vs Control). Baseline value of endpoints was included, with a monotone effect using a Dirichlet distribution.

Variables adjusted för are: - Binge drinking (Drinking at least 6 glass on the same occassion, YES or NO) - Age - Mental health status (History of psychiatric health issues of prescription of anti-depressant)

Imputations using MICE (5 imputaed data sets).

Study results

Analyse and present results for trial 3 and 4.

Primary:
How often in the last month have there been negative thoughts about your cancer suddenly and by itself?

Co-primary:
How severe has the sudden negative intrusive thoughts been?

Secondary 1:
Depressed mood

Secondary 2:
How would you like to describe your quality of life in the last month?

Secondary 3:
Have you experienced periods of intense anxiety, worry or panic

Secondary 4:
Have you woken up at any time during the night with worry, anxiety or an unpleasant feeling the last month?

Main analysis of endpoints

Odds ratio describes the relative (Active vs Control) of more worse outcomes. That is large values (>1) of odds ratio means that patients on Active are worse off compared to Control. Small values (<1) of odds ratio means that patients on Active are better off compared to Control.

Patients assigned to Active group had higher tendency to poor QoL (OR 2.0 and 1.6 for trial 3 and 4, respectively. Patients assigned to Active group had higher tendency to wake up during the night with worry (OR 2.6 for trial 4). There is slightly higher probability that patients on Active never have intrusive thought for trial 3. The opposite is the case for trial 4.

Primary:

How often in the last month have there been negative thoughts about your cancer suddenly and by itself?

Large value of odds ratio favors Control. Posterior probability that odds ratio > 1 is 19%.

Co-primary:

How severe has the sudden negative intrusive thoughts been?

Secondary 1:

Depressed mood

There is a higher probabaility that patients on Active has depressed mood.

Secondary 2:

How would you like to describe your quality of life in the last month?

Patients on Active has poorer QoL

Secondary 3:

Have you experienced periods of intense anxiety, worry or panic

Patients on Active has more anxiety and worry

Secondary 4:

Have you woken up at any time during the night with worry, anxiety or an unpleasant feeling the last month?

Supplementary material

Supportive senstivity analyses

Unadjusted analysis is model with only treatment factor (Active or Control) is in the model (complete cases, no imputations).

Frequentist analysis use same adjustment varoables as main analysis as well as pooled across the 5 imputed data sets

MCMC diagnostics

Primary:

How often in the last month have there been negative thoughts about your cancer suddenly and by itself?

Co-primary:

How severe has the sudden negative intrusive thoughts been?

Secondary 1:

Depressed mood

Secondary 2:

How would you like to describe your quality of life in the last month?

Secondary 3:

Have you experienced periods of intense anxiety, worry or panic

Secondary 4:

Have you woken up at any time during the night with worry, anxiety or an unpleasant feeling the last month?