| Protocol ID | NCT06810388 |
| Registration Date | 2025-02-05 |
| Status | not yet recruiting |
| Sponsor | Xiaowan Li |
| Country | – |
| Industry | not industry |
| Blinding | blinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2025-07-01 |
| Last Patient Out | 2026-07-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT06810388
Effect of a Family-centred Empowerment Model-based Intervention on the Caregiving Capacity and Preparedness of Caregivers of Children With Malignant Neoplasms: a Protocol for a Quasi-experimental Study
| Field |
GLM
glm-5.1 6847ms / 9443 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5064ms / 10727 tok |
OPENAI
gpt-4o Thinking: o3 3853ms / 9261 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 | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study is a non-randomized, single-group interventional trial (quasi-experimental study), which does not meet the criteria for an RCT.
|
N/A
fully powered RCT → fully powered RCT → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — With 128 participants and primary outcomes focused on clinical effectiveness (caregiving capacity and preparedness), this is a fully powered study designed to test the intervention's efficacy rather than assess feasibility.
Thinking: N/A — This is a quasi-experimental study with non-randomized allocation, not an RCT.
|
N/A
N/A → N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — This is a quasi-experimental study, which is an observational study, not a randomized controlled trial (RCT).
Thinking: N/A — The study is a non-randomized quasi-experimental design, not an 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 | 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 | yes | yes | yes | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study assesses caregiver preparedness, caregiving capacity, psychological distress, and self-efficacy, but does not utilize any validated Quality of Life (QoL) instruments.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures caregiver preparedness, caregiving capacity, depression/anxiety/stress, and self-efficacy, but does not use validated quality of life instruments like EORTC QLQ-C30, FACT-G, SF-36, or EQ-5D.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial measures caregiving capacity, preparedness, depression, anxiety, stress, and self-efficacy but does not use any of the validated quality of life instruments such as EORTC QLQ-C30, FACT-G, or similar.
|
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 |