A randomized controlled trial of cognitive behavioral therapy and bright light therapy for insomnia and fatigue during breast cancer treatment: SleepCaRe trial.
Bibliographic record
Abstract
12009 Background: Women on chemotherapy for breast cancer (BC) report high levels of insomnia and fatigue. This trial aimed to test the main effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Bright Light Therapy (BLT) on insomnia and fatigue symptoms. Methods: This multi-center, randomized, controlled, 2 x 2 factorial, superiority, trial enrolled 219 women receiving cytotoxic chemotherapy for any stage BC. Interventions were: (1) neither CBT-I nor BLT (sleep hygiene education; SHE), (2) BLT, (3) CBT-I, and (4) BLT+CBT-I. The 6-week interventions included one telehealth, 1:1 session followed by emails and a mid-treatment call. Assessments occurred at baseline, 3 and 6 weeks. Dual primary outcomes were the insomnia severity index (ISI) and PROMIS Fatigue. Intention-to-treat analyses were latent growth models. Effect sizes are standardized mean differences (SMDs). Results: Mean age was 50.7y and 24% had metastatic cancer. At baseline, average ISI was 13.24 (SD = 5.48; sub-threshold insomnia), and fatigue was 59.57 (SD = 7.91; moderate fatigue). 88% (n = 198) completed the telehealth session. 75% (n = 165) reported post-treatment outcomes. ISI and fatigue decreased in all conditions (see Table). CBT-I improved ISI (mean difference = -2.03; p = .001; SMD = -0.37), but BLT did not (mean difference = -1.09; p = .082; SMD = -0.20). Neither intervention affected fatigue (SMDs -0.06 to -0.07; p > 0.60). There was no BLTxCBT-I interaction for ISI nor fatigue ( p > 0.50). Conclusions: In patients receiving chemotherapy for BC, brief CBT-I can improve insomnia but not fatigue symptoms. BLT did not improve insomnia or fatigue. We found no evidence of an interaction between BLT and CBT-I. During chemotherapy, fatigue may not be responsive to brief sleep and circadian-oriented treatments. Clinical trial information: ACTRN12620001133921 . Between group (main effects) and within group (change). ISI [95% CI] P, SMD Fatigue [95% CI] P, SMD Main Effects BLT -1.09 [-2.31, 0.14] p = .082, SMD = -0.20 -0.49 [-2.87, 1.88] p = .68, SMD = -0.06 CBT-I -2.03 [-3.25, -0.81] p = .001, SMD = -0.37 -0.54 [-2.92, 1.83] p = .65, SMD = -0.07 Change: 0–6 weeks SHE -3.41 [-4.65, -2.17] p < .001, SMD = -0.62 -3.75 [-6.16, -1.34] p = .002, SMD = -0.47 BLT -4.89 [-6.12, -3.66] p < .001, SMD = -0.89 -3.75 [-6.13, -1.37] p = .002, SMD = -0.47 CBT-I -5.83 [-7.12, -4.54] p < .001, SMD = -1.06 -3.80 [-6.30, -1.31] p = .003, SMD = -0.48 CBT-I+BLT -6.53 [-7.88, -5.18] p < .001, SMD = -1.19 -4.79 [-7.44, -2.14] p < .001, SMD = -0.61
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.015 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".