| Protocol ID | NCT05368116 |
| Registration Date | 2022-05-10 |
| Status | completed |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Country | India |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2021-11-01 |
| Last Patient Out | 2021-12-05 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 65 Years |
NCT05368116
Effectiveness of Video Assisted Self Management Program on Chemotherapy Side Effects in Terms of Knowledge, Self Efficacy and Severity of Side Effects Among the Cancer Patient Receiving Chemotherapy at Oncology Day Care
| Field |
GLM
glm-5.1 8123ms / 10618 tok |
CLAUDE
claude-sonnet-4-20250514 5510ms / 12143 tok |
OPENAI
gpt-4o 3056ms / 10445 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
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is delivered to patients at the 'Oncology Day care' unit of the hospital, which is an ambulatory/outpatient setting where patients are not formally admitted (inpatient).
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is delivered in an oncology day care unit, which is an outpatient ambulatory care setting rather than an inpatient hospital ward.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is delivered in an outpatient setting at the Oncology Day Care unit, not requiring hospital admission.
|
OK |
| feasibility |
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This is a randomized controlled trial designed to evaluate clinical effectiveness with an enrollment of 60 participants, testing hypotheses to determine the intervention's impact on patient knowledge, self-efficacy, and the severity of chemotherapy side effects.
|
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This is a fully powered RCT with 60 participants specifically designed to test the clinical effectiveness of video-assisted self-management program on knowledge, self-efficacy, and severity of chemotherapy side effects with primary clinical outcomes and formal hypotheses testing.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The study is designed for clinical effectiveness with an enrollment of 60 participants, focusing on clinical outcomes such as knowledge, self-efficacy, and severity of chemotherapy side effects.
|
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 | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | 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 |