NCT06420609

Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial

Extracted Fields (from Registry)
Protocol IDNCT06420609
Registration Date2024-05-20
Statusactive, not recruiting
SponsorUniversitat Internacional de Catalunya
CountrySpain
Industrynot industry
Blindingblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2024-05-14
Last Patient Out2025-12-21
Publicationn
Gender %ALL
Mean Age18 Years - 100 Years
LLM Classifications (Side-by-Side)
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
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