| Protocol ID | NCT04966468 |
| Registration Date | 2021-07-19 |
| Status | Unknown Status |
| Sponsor | Fondazione ANT Italia ONLUS |
| Country | Italy |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-12-14 |
| Last Patient Out | 2022-03-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 70 Years |
NCT04966468
Look of Life 2.0. Virtual Reality for Cancer Patients in Home Palliative Care
| Field |
GLM
glm-5.1 11597ms / 13493 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 10111ms / 15308 tok |
OPENAI
gpt-4o Thinking: o3 3333ms / 13311 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 | home care | home care | home care | 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 | yes | yes | yes | OK |
| intervention_psychological |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This study tests virtual reality technology versus tablet videos for distraction and mood enhancement, with no structured psychological therapy like CBT, psychotherapy, or other named therapeutic approaches mentioned.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial uses VR for distraction and relaxation, which does not qualify as a structured psychological therapy.
|
OK |
| intervention_complex |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention solely involves the use of virtual reality technology for psychological support, which falls under a single category of an immersive technology intervention without additional distinct components from different categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial tests a virtual reality (VR) device intervention in a palliative care setting rather than testing palliative care itself as the intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is virtual reality technology to manage symptoms in cancer patients who happen to receive home palliative care, not palliative care consultation or service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention being tested is virtual reality, not palliative care itself.
|
OK |
| intervention_education | no | no | no | 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 → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary and secondary outcomes, such as anxiety, depression, pain, and short-term psychophysical symptoms, are classified as symptom, quality of life, or dignity measures.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study includes feasibility metrics such as identifying the most beneficial VR content types and average usage times for effectiveness.
Thinking: yes — Secondary outcomes include feasibility metrics to determine optimal VR content type and usage patterns for effectiveness.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes are related to symptoms, quality of life, and psychophysical comfort in cancer patients.
Thinking: yes — The study includes feasibility metrics like headset usage time and content preference, which are outside symptom/QoL/cost domains.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |