Recording and reporting of adverse events during a randomized controlled trial of cognitive behavioural therapy for insomnia (CBT-I) among cancer survivors.

BACKGROUND/AIMS: Sleep disturbances are one of the biggest barriers to resuming normal functioning following cancer treatment. Cognitive behavioral therapy for insomnia (CBT-I) has demonstrated efficacy in cancer survivors but few studies have recorded adverse events (AEs) that occur during treatment. The purpose of this study was to report the prevalence, severity, and attribution of AEs during CBT-I with cancer survivors.

METHODS

Cancer survivors from Atlantic Canada with insomnia and comorbid cognitive impairment were recruited to participate in a randomized controlled trial of CBT-I. Participants reported the prevalence, severity, and attribution of AEs at mid-treatment (4 weeks) and post-treatment (8 weeks). The likeliness of AEs being related to treatment was also rated by an independent clinician.

RESULTS

Of the 122 cancer survivors who completed treatment (  = 60.3, 77.9% women), 72 reported a total of 197 AEs. At mid-treatment, participants reported 113 AEs, but only 11 were rated as being attributed to the intervention. At post-treatment, participants did not report any AEs attributed to the intervention. An independent rater attributed more AEs to the treatment than the participants at both time points (4 weeks: 16 vs. 11, 8 weeks: 1 vs. 0). Gender ( = .014) and pre-treatment anxiety ( < .001) were associated with reporting an AE.

DISCUSSION

CBT-I is a safe treatment that is well-tolerated by cancer survivors. The majority of participants did not experience AEs that could be attributed to the treatment. Clinicians should continue to recommend CBT-I as the first-line treatment for cancer survivors experiencing insomnia symptoms.

TRIAL REGISTRATION

This study is a secondary analysis of a randomized controlled trial titled 'Addressing Cancer Treatment-Related Insomnia Online in Atlantic Canada (ACTION) study' (https://www.clinicaltrials.gov/search?cond=NCT04026048 identifier: NCT04026048).