| Protocol ID | NCT06590506 |
| Registration Date | 2024-09-19 |
| Status | recruiting |
| Sponsor | Centro Nacional de Investigaciones Oncologicas CARLOS III |
| Country | Spain |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2023-03-02 |
| Last Patient Out | 2028-01-01 |
| Publication | n |
| Gender % | FEMALE |
| Mean Age | 18 Years - |
NCT06590506
High Definition Medicine: Establishment of a Cohort of Patients With Advanced Cancer for Prospective High-resolution Follow-up
| Field |
GLM
glm-5.1 6717ms / 10015 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5157ms / 11411 tok |
OPENAI
gpt-4o Thinking: o3 7000ms / 9864 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 | 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 | yes | yes | yes | 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 | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital |
no
no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The use of wearable electronic devices (activity bracelets) for continuous monitoring and data collection throughout the study is the central primary intervention, without which the study's core objectives could not be met.
|
yes
yes → no → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — This is an observational study using wearable devices solely for data collection and monitoring, not as a therapeutic intervention - removing the digital component would not change the core study design of collecting clinical, analytical and epidemiological variables from cancer patients.
Thinking: no — This is an observational study where wearables are used solely for data collection to monitor patients' vital signs and activity, not as a therapeutic intervention.
|
yes
yes → no → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: no — Wearables are used for data collection and monitoring, not as a core delivery mechanism of the intervention.
Thinking: yes — Continuous physiological and activity monitoring with a wearable device is the core intervention and is essential to the study.
|
|
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study includes PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) as a secondary outcome measure, which is a validated instrument for assessing patient-reported symptoms and adverse events.
Thinking: yes — Study includes Goldberg-GHQ28 (measures depression/anxiety symptoms) and PRO-CTCAE (measures patient-reported symptoms/adverse events) as secondary outcomes.
|
yes
no → no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study does not utilize symptom measures or validated instruments related to symptoms; it focuses on clinical, analytical, and epidemiological variables without direct symptom assessment.
Thinking: yes — Secondary outcomes include PRO-CTCAE and the Goldberg GHQ-28, validated instruments that directly measure patient symptoms such as treatment-related adverse symptoms and anxiety/depression.
|
OK |
| outcome_qol | yes | yes | yes | 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 |