Safety and adverse events

Study staff will review self-report measures on completion for missing data and to monitor distress levels. If a patient endorses a score ≥11 on the depression subscale of the HADS, the PI will be notified and either the PI or one of the trained study therapists will contact the patient via telephone to conduct a risk/safety assessment. If the patient requires further outpatient services (eg, pharmacotherapy) or is at risk for self-harm, study staff will make the necessary referrals for treatment and/or urgent psychiatric care. If suicidality or risk of harm to others is otherwise discovered at any study visit, the patient will be referred to the appropriate services.

At weekly meetings, the research team will discuss summaries of adverse events by treatment group, and all serious adverse events will be reported to the PI, the DF/HCC Institutional Review Board (IRB) and the appropriate federal agencies (eg, National Cancer Institute) regardless of any judgement of their relatedness to the study. The research team will also discuss summary reports of treatment retention and reasons for dropout or withdrawal by treatment group. Patients who withdraw will be asked if they are willing to complete assessment measures. The project will be stopped immediately if at any point the DF/HCC IRB or the study investigators judge that the risks of study procedures outweigh the benefits. Furthermore, the DF/HCC IRB will conduct trial auditing if deemed necessary throughout the study.