| Protocol ID | NCT06022965 |
| Registration Date | 2023-09-05 |
| Status | recruiting |
| Sponsor | City of Hope Medical Center |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2023-07-24 |
| Last Patient Out | 2027-01-24 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 65 Years - |
NCT06022965
Geriatric Assessment (GA)-Driven Interventions With Supportive Care (The GAIN-S Trial): Telemedicine to Increase Goal Concordant Care for Older Adults With Cancer in the Community
| Field |
GLM
glm-5.1 10794ms / 9585 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 7382ms / 10962 tok |
OPENAI
gpt-4o Thinking: o3 3673ms / 9431 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
shaky reasoning✓ Unanimous
Initial: outpatient
|
outpatient
outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The intervention consists of telemedicine-based geriatric assessments and supportive care delivered to cancer patients in the community who are visiting for their cancer treatments but not admitted to the hospital.
|
outpatient
mixed → outpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: outpatient — The intervention is delivered via telemedicine, indicating that patients are not admitted to a hospital or inpatient facility during the study.
|
OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The GAIN-S intervention and geriatric assessments are delivered remotely via telemedicine to older adults with cancer located in underserved community settings, making it an outpatient/community-based study rather than a traditional inpatient hospital setting.
|
other
other → home care → other
shaky reasoning✓ Unanimous
Initial: other
Requery: home care — The intervention specifically uses telemedicine to deliver GA-based interventions to older adults with cancer in their community/remote settings, indicating care is delivered to patients in their home environment.
Thinking: other — The intervention is delivered entirely through telemedicine to patients in community settings, not at a specific facility type.
|
other
hospital → other → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is delivered via telemedicine in a community setting, not requiring hospital admission or inpatient care.
Thinking: other — GA-based interventions are delivered via telemedicine in community/outpatient settings, not requiring inpatient admission, hospice, nursing home, or in-person home visits.
|
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 | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The GAIN-S intervention combines multiple distinct components including geriatric assessment, supportive care interventions, telemedicine delivery, and care coordination with multi-specialty teams, representing a multicomponent intervention that integrates assessment, clinical care, and technology delivery modalities.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial combines geriatric assessment, telemedicine, and multi-specialty team referrals, integrating multiple components from different categories for a complex, multi-faceted intervention.
|
OK |
| intervention_acp | yes | yes | yes | OK |
| intervention_music | no | no | no | OK |
| intervention_screening |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial evaluates a screen-then-treat model where the Geriatric Assessment (GA) is used to identify vulnerabilities and guide subsequent GA-based interventions via telemedicine, meaning the screening itself is not the primary intervention being tested.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is a geriatric assessment-driven intervention program delivered via telemedicine (GAIN-S), not the screening/assessment tool itself - the geriatric assessment is used to guide interventions rather than being the primary intervention being evaluated.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial evaluates geriatric assessment-driven interventions for supportive care, not screening; screening is used to guide interventions, not as the intervention being tested itself.
|
OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |