NCT01949974

Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial

Extracted Fields (from Registry)
Protocol IDNCT01949974
Registration Date2013-09-25
StatusWithdrawn
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
CountrySpain
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2013-06-01
Last Patient Out2016-06-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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