| Protocol ID | NCT04627376 |
| Registration Date | 2020-11-13 |
| Status | recruiting |
| Sponsor | Cyprus University of Technology |
| Country | Cyprus |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-09-24 |
| Last Patient Out | 2026-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04627376
Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
| Field |
GLM
glm-5.1 7735ms / 9079 tok |
CLAUDE
claude-sonnet-4-20250514 9301ms / 10359 tok |
OPENAI
gpt-4o 2979ms / 8908 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 | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility |
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — The trial evaluates clinical effectiveness using clinical and patient-reported primary outcomes (pre-cachexia stage) with an enrollment of 60.
|
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This study has 60 participants with primary outcomes focused on clinical effectiveness (preventing cachexia progression) rather than feasibility metrics, and includes formal sample size calculation considerations for detecting clinical changes.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The study involves 60 participants and aims to assess clinical effectiveness with primary clinical outcomes related to cachexia.
|
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 | yes | yes | yes | 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 |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The outcomes focus on cachexia prevention, body composition, biomarkers (CRP, albumin), and quality of life measures (FAACT, CarGOQoL) rather than specific symptom assessment using validated symptom instruments.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial does not include any symptom-specific outcome measures, using mainly physiological and QoL assessments instead.
|
OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study includes caregiver quality of life outcomes which fall outside the symptom/QoL/dignity/cost categories for patients.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes family caregiver quality of life as an outcome, which is not covered by symptom/QoL/dignity/cost categories.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |