A nurse-led intervention to enhance quality of life (QOL) among early phase cancer clinical trial participants.
Bibliographic record
Abstract
336 Background: Efforts to address supportive care (SC) concerns among EPCT participants are key for improving QOL and decreasing symptom burden. Clinical Research Nurses (CRNs) are uniquely positioned to address SC concerns among EPCT participants, and thus we sought to determine feasibility and acceptability of a nurse-led intervention in this population. Methods: We conducted an open pilot study, prospectively enrolling EPCT participants, CRNs, and collaborative team clinicians (clinicians) from palliative care, social work, and psychology at Massachusetts General Hospital from 7/2023-09/2024. The intervention included three structured CRN visits with EPCT participants and implementation of bi-monthly collaborative team meetings. Participants completed patient-reported outcomes (PROs) at enrollment and three monthly timepoints: QOL (Functional Assessment of Cancer Therapy-General [FACT-G]), hope (Herth Hope Index), symptoms (Edmonton Symptom Assessment System), and coping (Brief-Cope). We assessed CRN and clinician acceptability (Acceptability of Intervention Measure [AIM]). Exit interviews with CRNs and clinicians assessed perceptions of usefulness, effectiveness, relevance. The primary endpoint was feasibility, defined as ≥ 60% enrollment of patients approached and > 70% of participants completing ≥ 60% of PROs. Results: We enrolled 50/61 patients approached (enrollment rate: 85%; median age: 58.7 years [IQR: 52.8-65.7 years], 60% female, 94% metastatic cancer, ECOG 0=38% and ECOG 1=62%). Most common cancers were gastrointestinal (22%) and breast (7%). At enrollment, 24% (n=12) reported bill paying concerns, 54% had seen a social worker (n=27), and 24% (n=12) had seen palliative care. Median time on trial (TOT) was 3.4 months. Taking TOT in account, 90% (n=45) completed ≥ 60% of PROs. Changes in mean PRO scores from baseline to month 3 showed improvement over time: FACT-G total (+5.8, p<0.01), FACT-G subscales: physical (+1.7, p=0.04), social (+1.3, p=0.04), emotional (+1.8, p=0.02). Among 10 CRNs and 10 clinicians approached, all participated, and acceptability of the intervention was demonstrated by high AIM scores (mean=17.6; scale range: 4-20) and exit interviews (themes identified: appreciated patient-centric collaboration, logistically possible and meaningful, unexpected positive outcomes). Conclusions: In this pilot study, we demonstrated feasibility and acceptability of an innovative nurse-led intervention to address SC concerns among EPCT participants. Notably, we found promising results for improved PROs over time and favorable exit interview feedback, which underscore the intervention’s potential usefulness, effectiveness, and relevance. Findings support the need for randomized trials to assess efficacy of this intervention.
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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 | 0.060 | 0.110 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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; both teacher heads agree on what is shown here.
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".