| Protocol ID | NCT03068013 |
| Registration Date | 2017-03-01 |
| Status | recruiting |
| Sponsor | Università degli Studi di Ferrara |
| Country | Italy |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2018-10-11 |
| Last Patient Out | 2024-12-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03068013
Effectiveness of a Brief Manualized Intervention Managing Cancer and Living Meaningfully (CALM) Adapted to the Italian Cancer Care Setting. Study Protocol for a Randomized Controlled Trial
| Field |
OPENAI
gpt-4o Thinking: o3 3994ms / 12767 tok |
GLM
glm-5.1 10491ms / 12994 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 8344ms / 14685 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
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is delivered as outpatient psychotherapy sessions rather than requiring hospital admission, fitting an outpatient clinic or community setting classification.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The psychotherapeutic intervention is delivered in an outpatient psycho-oncology clinic setting to non-hospitalized advanced cancer patients.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention consists of individual psychotherapy sessions delivered at university hospital outpatient settings, which constitutes outpatient clinic care rather than inpatient hospitalization.
|
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 | yes | yes | yes | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp |
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The CALM intervention includes preparing for the future and addressing mortality, which aligns with goals of care discussions typical in Advance Care Planning.
Thinking: no — CALM is a psychotherapeutic intervention for distress and meaning-making; it does not include structured advance care planning or formal goals-of-care discussions as a core component.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The CALM psychotherapy intervention addresses preparing for the future and mortality but does not include structured advance care planning components like advance directives or POLST as a core focus.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The CALM intervention explicitly includes 'Preparing for the future, sustaining hope and facing mortality' as one of its four core domains, along with structured preparation for end-of-life discussions, which constitutes advance care planning.
Thinking: no — While CALM addresses 'preparing for the future and facing mortality' as one domain, it is a psychotherapy intervention focused on depression and psychological well-being without explicit advance care planning components like advance directives or structured goals-of-care conversations.
|
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 — The trial tests a psychotherapeutic intervention called CALM for cancer patients, not palliative care itself.
|
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a psychological intervention (CALM therapy) being tested in advanced cancer patients, not palliative care consultation or service delivery as the intervention itself.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | yes | yes | yes | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |