Phase 2 trial of Symptom screening with Targeted Early Palliative care (STEP) for patients with advanced cancer.
Bibliographic record
Abstract
11604 Background: Routine early palliative care (EPC) by specialized teams improves quality of life for patients with advanced cancer, but may not be scalable. To plan for a larger randomized controlled trial, we conducted a phase 2 trial of STEP, a novel intervention of targeted EPC based on symptom screening. Methods: Participants with advanced cancer, ECOG 0-2, and clinical prognosis ≥6 months were recruited from lung, gastrointestinal, genitourinary, breast and gynecology outpatient clinics. Symptoms were screened at every outpatient visit using the Edmonton Symptom Assessment System-revised (ESAS-r). Moderate to severe symptom scores (≥4/10 for pain, nausea, dyspnea, depression, anxiety; ≥7/10 for fatigue, appetite, drowsiness, well-being) triggered an e-mail to a nurse, who called the patient, offering an EPC visit. Participants completed outcome measures at baseline, 2, 4 and 6 months (primary endpoint). Trial feasibility criteria were: i) ≥100 patients accrued in 12 months; ii) ≥70% complete screening for ≥70% of visits; iii) ≥60% of those for whom a call is triggered meet at least once with the EPC team; iv) ≥60% complete measures at each endpoint. Results: From 11/2016-1/2018, 116 patients were enrolled; 89/116 (77%) completed screening for ≥70% of visits and 59% (69/116) received a call triggered by symptoms. Of those receiving a call, 62% (43/69) received EPC; 3 further patients were referred by their oncologist. Measure completion was 79% (81/116) at 2, 61% (71/116) at 4, and 57% (66/116) at 6 months. By trial end (6 months), patients who received a call and accepted EPC involvement had better symptom control (ESAS-r-CS mean change in those receiving vs. deferring EPC: -0.07±16.9 vs 11.8±13.7, p = 0.02) and less deterioration in mood (PHQ-9: -0.4±3.4 vs 2.6±2.3, p = 0.003). There was no difference between those receiving versus deferring EPC in quality of life (FACIT-Sp: -4.7±13.6 vs -3.2±15.4, p = 0.75; QUAL-E: -2.6±8.4 vs -1.5±11.0, p = 0.62), or satisfaction with care (FAMCARE-P-16: -3.2±7.9 vs -3.5±6.1, p = 0.79). Conclusions: STEP is feasible in patients with advanced cancer. More than half of patients have moderate to severe symptoms, and acceptance of the triggered EPC visit should be encouraged.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 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) | 0.013 | 0.002 |
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".