| Protocol ID | NCT04552587 |
| Registration Date | 2020-09-17 |
| Status | completed |
| Sponsor | Medical University of South Carolina |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-12-04 |
| Last Patient Out | 2021-10-10 |
| Publication | y |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04552587
A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
| Field |
CLAUDE
claude-sonnet-4-20250514 6389ms / 12251 tok |
OPENAI
gpt-4o 4289ms / 10577 tok |
GLM
glm-5.1 7127ms / 10749 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
shaky reasoning✓ Unanimous
Initial: other
|
other
home care → other
shaky reasoning✓ Unanimous
Initial: home care
Requery: other — The intervention includes an outpatient clinic visit, either in person or remotely, and the delivery of a mobile app, indicating it occurs in a setting outside inpatient hospital care.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is primarily delivered through a mobile app and can be provided via an outpatient clinic visit or virtually, meaning it is not delivered in an inpatient hospital, home, hospice, or nursing home setting.
|
OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility 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 |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines multiple distinct components including a care planning clinic visit with needs assessment, tailored educational materials and referrals, plus a separate mobile app with ongoing support features, representing educational, technological, and care coordination components working together.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines educational and psychological support through a care planning clinic and a mobile App, integrating different types of support for caregivers and survivors.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines multiple interacting components from different categories, specifically a clinical/organizational needs assessment and care planning visit, educational materials, and a behavioral mobile health App.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is a mobile app-based nutritional support intervention for head and neck cancer survivors and caregivers, not a palliative care consultation or service delivery intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial focuses on a nutritional support program with a mobile app, not a palliative care intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The study tests a mobile-support program for nutritional caregiving in head and neck cancer survivors rather than a palliative care consultation or service.
|
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 | 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 |