Impact of early phase study enrollment for pediatric oncology patients on symptom burden and quality of life (QOL): Early report of trial-in-progress results.
Bibliographic record
Abstract
e23195 Background: Pediatric patients with relapsed or refractory malignancy have few options. The quality of life (QoL) impact for enrolling in a phase I or II trial compared to those not participating is unknown. This information is invaluable to the consenting process as well as to clinical trial design. The primary aim was to determine if those enrolled on a phase I or II trial had lower scores on the Symptom Screening in Pediatrics Tool (SSPedi) total score compared to those not enrolled on a trial. Methods: This Canadian multi-site study had nine sites open for accrual. SSPedi was calculated based on patient reports for 8-18 years and parent-proxy reports for all children. The total score is the sum of 15 items’ 4 Likert scale scores, score ranges from 0 to 60 (worst possible). Scores from baseline, 4 weeks and 8 weeks of those enrolled on an early phase trial were compared to those who did not enroll in such trials. Results: Of the 54 49 patients, 21 (43%) patients were enrolled on an early phase trial and 28 (57%) patients were not enrolled in a study. For those enrolled on the study at enrollment time, 4 weeks and 8 weeks time points, the total SSPedi score for the participant mean was 11.1 (SD 8.1), 9.2 (SD 6.3) and 10.1 (8.3) respectively compared to those not enrolled on a study with mean scores at the same time points of 13.8 (SD 8.6), 13.5 (SD 9.4), and 15.4 (SD 12.6). Conclusions: These results suggest that it is feasible to evaluate patients enrolled and not enrolled on early phase trials, and to compare their symptom experience. Further efforts will focus on more recruitment and using the PedsQL 3.0 Acute Cancer Module to further define differences in QoL. The results suggest that those enrolled in an early phase trial had an improved quality of life compared to those non-enrolled. This research is supported through granting from the C17 Council and Kindred Foundation. [Table: see text]
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.040 | 0.045 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".