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

Extracted Fields (from Registry)
Protocol IDNCT00921232
Registration Date2009-06-16
Statuscompleted
SponsorCentre Oscar Lambret
CountryFrance
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2007-04-01
Last Patient Out2008-02-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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