| Protocol ID | NCT05722847 |
| Registration Date | 2023-02-10 |
| Status | completed |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2023-03-14 |
| Last Patient Out | 2025-05-02 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT05722847
Development of an Enhanced Risk Stratification System for Patients With Hospital-diagnosed Advanced Lung Cancer
| Field |
GLM
glm-5.1 6733ms / 9349 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4906ms / 10681 tok |
OPENAI
gpt-4o Thinking: o3 4041ms / 9200 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | mixed |
outpatient
mixed → mixed → outpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: mixed — The study includes patients who are initially hospitalized (inpatient) for their lung cancer diagnosis, then transitions to outpatient care with 90-day follow-up monitoring after hospital discharge.
Thinking: outpatient — The intervention (PRO symptom monitoring, navigation, and palliative care) is delivered for 90 days AFTER hospital discharge via web/telephone, making this an outpatient study despite initial hospital diagnosis.
|
outpatient
outpatient → outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The intervention involves web- or telephone-based PRO symptom monitoring after hospital discharge, indicating outpatient status during the intervention phase.
Thinking: outpatient — Intervention consists of post-discharge web/telephone symptom monitoring and supportive outpatient care, so patients are not admitted during the study treatment phase.
|
– |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | N/A | N/A | N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is an observational study developing a risk stratification system and implementing supportive care interventions, not testing a screening tool itself as the primary intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study evaluates supportive care feasibility based on risk stratification, not testing screening as an intervention.
|
OK |
| intervention_palliative | no |
yes
yes → no → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — This is an observational study testing a risk stratification system and patient-reported outcome monitoring, where palliative care referral is just one component being measured as an outcome rather than the primary intervention being tested.
Thinking: no — This observational study tests a risk stratification system for lung cancer patients where palliative care is one of several supportive services recommended for high-risk patients, not the intervention being evaluated.
|
no
no → yes → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The trial involves recommending palliative care as part of supportive care interventions for the high-risk group, making palliative care the intervention being tested.
Thinking: yes — The study’s intervention involves a triggered supportive-care pathway that specifically recommends and measures receipt of palliative care consultation for high-risk patients.
|
|
| intervention_education | no | no | no | OK |
| intervention_digital | no | yes | yes | – |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |