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

Extracted Fields (from Registry)
Protocol IDNCT03068013
Registration Date2017-03-01
Statusrecruiting
SponsorUniversità degli Studi di Ferrara
CountryItaly
Industrynot industry
Blindingblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2018-10-11
Last Patient Out2024-12-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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