Recording and reporting of adverse events during a randomized controlled trial of cognitive behavioural therapy for insomnia (CBT-I) among cancer survivors
Bibliographic record
Abstract
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. 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. Of the 122 cancer survivors who completed treatment (Mage = 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 (p = .014) and pre-treatment anxiety (p < .001) were associated with reporting an AE. 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. 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).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.052 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".