| Protocol ID | NCT00921232 |
| Registration Date | 2009-06-16 |
| Status | completed |
| Sponsor | Centre Oscar Lambret |
| Country | France |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2007-04-01 |
| Last Patient Out | 2008-02-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT00921232
Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient
| Field |
OPENAI
gpt-4o Thinking: o3 2352ms / 8107 tok |
GLM
glm-5.1 8007ms / 8244 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4649ms / 9432 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 | outpatient | outpatient | outpatient | OK |
| setting_place |
other
hospital → home care → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: home care — The study focuses on the return to home for life-ending patients, indicating the intervention is intended to be delivered at home.
Thinking: other — Questionnaires are given during an outpatient consultation at a cancer center, not during an inpatient hospital stay.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention involves completing questionnaires during a consultation (outpatient setting) for patients for whom a return to home is planned, rather than being admitted to a hospital.
|
other
other → other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention consists of questionnaires administered during a consultation, which indicates an outpatient clinic setting rather than inpatient hospital care.
Thinking: other — The intervention consists of questionnaires administered during consultations at the announcement of palliative care, which typically occurs in an outpatient clinic setting.
|
OK |
| feasibility |
N/A
fully powered RCT → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: N/A — The study is observational and focuses on assessment using questionnaires rather than testing a clinical intervention.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study design is a single-group interventional study without randomization or a control group, making it an observational cohort study rather than an RCT.
|
N/A
fully powered RCT → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: N/A — This is an observational study using questionnaires to assess burden in patient-caregiver dyads, not a randomized controlled trial.
|
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 → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention consists of the administration of questionnaires for assessment purposes, not for testing a screening tool as an intervention.
|
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is administering questionnaires (HADS, FRI, CRA) to assess burden and relationships in patient-caregiver dyads, which is outcome measurement rather than testing a screening tool as the primary intervention.
|
OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The study focuses on assessing burden within patient/caregiver dyads using questionnaires, not on delivering palliative care as the intervention.
|
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a behavioral study using questionnaires to assess burden in patient-caregiver dyads, not palliative care consultation or service delivery itself.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention involves behavioral assessment through questionnaires, which falls under the psychological category.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial's intervention involves the use of questionnaires, which fits the 'psychological' category as it aims to assess mental states (anxiety, depression) and behavioral burden.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention consists of questionnaires and surveys administered during consultation, which falls under the psychological/behavioral assessment category.
|
OK |
| outcome_symptom |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial uses the HADS scale, which is a symptom measure for depression and anxiety, as a secondary outcome.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial includes the Hospital Anxiety and Depression Scale (HADS) as a secondary outcome measure to assess depression and anxiety.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study uses HADS (Hospital Anxiety and Depression Scale) as a secondary outcome measure, which is a validated symptom assessment instrument for anxiety and depression.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |