| Protocol ID | NCT01949974 |
| Registration Date | 2013-09-25 |
| Status | Withdrawn |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Country | Spain |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2013-06-01 |
| Last Patient Out | 2016-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT01949974
Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial
| Field |
GLM
glm-5.1 9754ms / 8858 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5071ms / 10127 tok |
OPENAI
gpt-4o Thinking: o3 2779ms / 8710 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 → mixed
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: mixed — The intervention explicitly includes outpatient monitoring, 24h phone assistance, home visits, and support should hospitalization be required, indicating both inpatient and outpatient care.
|
outpatient
mixed → outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: outpatient — The Integral Attention Program explicitly mentions outpatient monitoring, home visits, and 24h phone assistance, indicating the intervention is primarily delivered in outpatient settings where patients go home between visits.
Thinking: outpatient — The interventions involve outpatient monitoring, home visits, and phone assistance, with patients traveling from home for chemotherapy and clinic visits rather than being admitted.
|
outpatient
outpatient → outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The trial mentions outpatient monitoring, home visits, and emphasizes care without requiring admission, indicating an outpatient setting.
Thinking: outpatient — Interventions (palliative chemotherapy and the Integral Attention Program) are provided via outpatient visits, home monitoring, and phone support without requiring hospital admission.
|
OK |
| setting_place | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The experimental intervention being tested is the non-pharmaceutical Integral Attention Program (PAI), while the chemotherapy is considered the standard of care comparator.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The experimental intervention includes standard palliative chemotherapy, which is a pharmacologic drug intervention.
Thinking: no — The experimental intervention being tested is the Integral Attention Program (PAI), which is explicitly described as a non-pharmaceutical intervention involving care planning, psychological support, and other supportive services.
|
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The experimental intervention is the Integral Attention Program, which is non-pharmacological.
Thinking: no — The experimental intervention is the Integral Attention Program, a non-drug supportive care program, while chemotherapy is only the comparator arm.
|
OK |
| intervention_chemo_immuno_radio |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial actively tests and compares the effects of palliative chemotherapy against an integral attention program in patients with advanced cancer.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — This trial directly compares standard palliative chemotherapy as one of the active interventions being tested against an integral attention program.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial tests palliative chemotherapy as an active intervention in advanced cancer patients.
|
OK |
| intervention_complementary |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The Integral Attention Program (PAI) is a comprehensive supportive care plan involving psychological, social, and standard palliative support, rather than a specific Complementary and Alternative Medicine (CAM) modality like acupuncture, massage, or herbal remedies.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The Integral Attention Program includes art therapy and mindfulness as part of the comprehensive care intervention, which are complementary medicine modalities.
Thinking: no — The Integral Attention Program includes psychological support, art therapy, and mindfulness as supportive care components, but none of the specified CAM modalities (acupuncture, aromatherapy, massage, reflexology, yoga, meditation, Reiki, herbal remedies) are mentioned.
|
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial's Integral Attention Program does not include CAM modalities such as acupuncture or herbal remedies, focusing instead on psychological and social support, art therapy, and mindfulness.
Thinking: no — The Integral Attention Program offers psychosocial support and optional mindfulness practice, which is treated as psychological (like MBSR) rather than a complementary modality such as acupuncture or herbal remedies.
|
OK |
| intervention_device | no | no | no | OK |
| intervention_psychological |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The Integral Attention Program (PAI) provides comprehensive palliative care with general psychological and social support, which does not qualify as a named, structured psychological therapy.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The Integral Attention Program includes specialized psychological support and mindfulness, which are structured psychological interventions.
Thinking: no — While PAI includes optional psychological support and voluntary mindfulness, no specific named or structured psychological therapy (CBT, ACT, MBSR, etc.) is described as a core intervention.
|
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The Integral Attention Program includes non-specific psychological and social support, but it does not list a structured psychological therapy like CBT or MBSR.
Thinking: no — The Integral Attention Program offers general palliative support and optional mindfulness/art therapy but does not specify delivery of a named, structured psychological treatment such as CBT, ACT, MBSR, etc.
|
OK |
| intervention_complex | yes | yes | yes | OK |
| intervention_acp |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — While the Integral Attention Program includes guidance in decision-making and care planning, there is no mention of structured advance care planning conversations, advance directives, POLST, or other core ACP components as defined interventions.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The Integral Attention Program focuses on pain management, decision-making, and continuity of care but does not explicitly include structured advance care planning as a core component.
|
OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | 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 | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
chemotherapy
N/A → chemotherapy
shaky reasoning✓ Unanimous
Initial: N/A
Requery: chemotherapy — The trial investigates standard palliative chemotherapy, which utilizes cytotoxic agents, versus a non-pharmaceutical comprehensive care program in patients with advanced cancer.
|
chemotherapy
chemotherapy → chemotherapy
shaky reasoning✓ Unanimous
Initial: chemotherapy
Requery: chemotherapy — The intervention includes standard palliative chemotherapy for advanced cancer patients, which consists of cytotoxic agents used for cancer treatment.
|
chemotherapy
chemotherapy → chemotherapy
shaky reasoning✓ Unanimous
Initial: chemotherapy
Requery: chemotherapy — The intervention includes standard palliative chemotherapy, which is a cytotoxic agent used in the treatment of cancer.
|
OK |