| Protocol ID | NCT06420609 |
| Registration Date | 2024-05-20 |
| Status | active, not recruiting |
| Sponsor | Universitat Internacional de Catalunya |
| Country | Spain |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2024-05-14 |
| Last Patient Out | 2025-12-21 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 100 Years |
NCT06420609
Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial
| Field |
CLAUDE
claude-sonnet-4-20250514 7238ms / 10319 tok |
OPENAI
gpt-4o 4484ms / 8923 tok |
GLM
glm-5.1 7606ms / 9071 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | mixed | mixed | mixed | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | 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
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The Go-TAD intervention consists of 4 open-ended questions about death thoughts delivered during a medical visit, which is supportive conversation rather than a structured psychological therapy approach.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention involves general supportive conversations regarding death thoughts, not a structured psychological therapy.
|
no
no
shaky reasoning✓ Unanimous
Initial: no
|
OK |
| intervention_complex | no | no | no | OK |
| intervention_acp |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — While the intervention involves structured conversations about death thoughts with advanced cancer patients, it focuses on emotional distress and coping rather than the core ACP components of goals-of-care planning, advance directives, or care preferences.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention focuses on approaching death thoughts and emotional distress, not on structured Advance Care Planning.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The Go-TAD intervention focuses on addressing death thoughts to reduce distress and is not a structured advance care planning tool for future medical decisions.
|
OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The Go-TAD intervention involves asking open-ended questions about death thoughts during medical visits, which is a psychological intervention focused on communication and emotional support.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention fits the category of psychological as it involves addressing death thoughts to reduce emotional distress and improve the doctor-patient relationship.
|
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
OK |
| outcome_symptom |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measures emotional distress using the DME questionnaire (4-item visual numerical scale for mood, coping, and concerns), which is a specific symptom assessment instrument.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcome measures emotional distress, which is a validated symptom measure related to mental health.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial uses the Palliative Outcome Scale (POS) as a secondary outcome, which is a symptom/distress measure explicitly listed in the classification guidelines.
|
OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures emotional distress, hopelessness, doctor-patient relationship, and quality of life, but does not specifically assess dignity, meaning in life, spiritual well-being, or existential themes using validated dignity-related instruments.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The outcomes focused on emotional distress, hopelessness, doctor-patient relationship, and quality of life rather than existential/spiritual themes or measures of dignity.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary and secondary outcomes focus on general emotional distress, hopelessness, and the doctor-patient relationship, none of which specifically measure dignity, existential distress, or spiritual well-being using dedicated instruments.
|
OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |