A non-inferiority randomized controlled trial comparing a home-based aerobic exercise program to a self-administered cognitive-behavioral therapy for insomnia in cancer patients
Bibliographic record
Abstract
Study Objectives: Thirty to sixty percent of cancer patients have insomnia symptoms, a condition which may lead to numerous negative consequences and for which an efficacious management is required. This randomized controlled trial aimed to assess the efficacy of a 6-week home-based aerobic exercise program (EX) compared to that of a 6-week self-administered cognitive-behavioral therapy for insomnia (CBT-I) to improve sleep in cancer patients. Method: Forty-one patients (78.1% female, mean age 57 years) with various types of cancer and having insomnia symptoms (Insomnia Severity Index [ISI] score ≥ 8) were randomized to the EX (n = 20) or the CBT-I (n = 21) groups. Measures were completed at pretreatment and posttreatment, as well as at 3- and 6-month follow-ups. Results: The EX intervention was statistically inferior to CBT-I in reducing ISI scores at posttreatment but was non-inferior at follow-up. However, no significant group-by-time interaction was found on any outcome and both interventions led to a significant improvement of subjectively-assessed sleep impairments on the ISI, the Pittsburgh Sleep Quality Index (PSQI) and most sleep parameters from a daily sleep diary at posttreatment corresponding to medium to large time effects (ds > 0.50 for ISI, PSQI, sleep onset latency, wake after sleep onset, total wake time and sleep efficiency). Conclusion: Both interventions produced significant improvements of sleep. However, EX was found to be significantly inferior to CBT-I in reducing ISI scores at posttreatment, which contradicts the initial non-inferiority hypothesis. These findings suggest that CBT-I remains the treatment of choice for cancer-related insomnia, although EX can lead to some beneficial effects. ClinicalTrials.gov Identifier: NCT02774369 https://clinicaltrials.gov/ct2/show/NCT02774369?term=NCT02774369&rank=1.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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".