| Protocol ID | NCT04308356 |
| Registration Date | 2020-03-16 |
| Status | completed |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Country | France |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-06-03 |
| Last Patient Out | 2024-07-07 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04308356
"What if we Talked About it…" Identification of Cancer Patients Taking up a Proposal for Discussions Dedicated to Anticipating Preferences of Care in the Event of Aggravation (DDA): Prospective Cohort Intervention Study Using a Mixed Methodology
| Field |
GLM
glm-5.1 6384ms / 10647 tok |
OPENAI
gpt-4o Thinking: o3 2879ms / 10484 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 9830ms / 12261 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
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention consists of scheduled interviews delivered in the outpatient oncology department of a university hospital, rather than during an inpatient admission.
|
other
other → other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention consists of outpatient interviews and assessments conducted at a university hospital, but does not require hospitalization or inpatient care.
Thinking: other — The DDA interviews and questionnaires are delivered to ambulatory oncology patients during clinic visits at a university hospital, i.e., an outpatient setting rather than an inpatient hospital stay.
|
other
hospital → hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: hospital — The study recruits patients from oncology departments in a university hospital and the interventions (clinical interviews with patients) are conducted in the hospital setting.
Thinking: other — The intervention consists of outpatient interviews and discussions conducted in the oncology department of a university hospital, not requiring patient admission or hospitalization.
|
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 | yes | yes | yes | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention is an advance care planning program (DDA) that facilitates discussions on end-of-life preferences, which is a core component and delivery method of palliative care.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention involves 'Discussions Dedicated to Anticipate preferences of care in the event of Aggravation (DDA)', which aligns with advance care planning and involves communication about palliative care preferences.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention is dedicated discussions about anticipating care preferences (DDA), which constitutes advance care planning - a core component of palliative care consultation and service delivery.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention focuses on advance care planning (ACP) discussions, a recognized category distinct from other interventions such as exercise or nutritional interventions.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The main intervention is DDA (Dedicated Discussions on Anticipating preferences of care) which involves structured communication and discussion processes, fitting into the psychological intervention category.
|
OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study uses API and HADS questionnaires, patient satisfaction questions, and process measures rather than validated quality of life instruments like EORTC QLQ-C30, FACT-G, or EQ-5D.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The study focuses on advance care planning and end-of-life care preferences, but does not use validated quality of life instruments like EORTC QLQ-C30, FACT-G, or others.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study uses the HADS (anxiety and depression scale) and API (autonomy preference index) questionnaires, but no validated quality of life instruments are mentioned.
|
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 |