Clinical trial · Interventional
Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care
Management of Symptoms in Patients With Advanced Lung Cancer: Early Incorporation of Patient and Family to Attention and Care Program in Oncology
NCT01631565CI-TRIAL-00024903PACOcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is recent evidence that early palliative care administered to patients helps for their quality of life (QoL). It is however not part of the standard multidisciplinary treatment. This study intents to evaluate the effect of early palliative care in patients with advanced Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early allocation to palliative care | Behavioral | — | UNRESOLVED |
| Nutritional counseling | Behavioral | — | UNRESOLVED |
| Psychoeducation. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard care
- description
- Usual care given to the patients. Treatment, follow-up.
- type
- EXPERIMENTAL
- label
- Early Palliative Care
- description
- Intervention: Early allocation to palliative care. Intervention: Nutritional counseling. Intervention: patient and care-taker psychoeducation, depression and anxiety evaluation. Standard of care: Oncological treatment according to stage of disease (IIIb/IV). Treatment: Chemotherapy (platins, taxans, TKIs) Baseline: BMI, and anthropometric characteristics (weight, height). Follow-up: During 6 chemotherapy circles with: Quality of Life (EORTC qlq-c30), HADS, ESAS and ZARIT.
- interventionNames
- Behavioral: Early allocation to palliative care
- Behavioral: Nutritional counseling
- Behavioral: Psychoeducation.
Primary outcomes (1)
- measure
- Global survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical stage IV * ECOG 0-2 * Patients treated virgin * Receive platinum-based chemotherapy Exclusion Criteria: * Suicide Risk * Delirium * Cognitive impairment
References
Publications (7)
- BACKGROUNDGore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000. PMID 11083884
- BACKGROUNDNieder C, Norum J. Early palliative care in patients with metastatic non-small cell lung cancer. Ann Palliat Med. 2012 Apr;1(1):84-6. doi: 10.3978/j.issn.2224-5820.2012.03.05. No abstract available. PMID 25841435
- BACKGROUNDFollwell M, Burman D, Le LW, Wakimoto K, Seccareccia D, Bryson J, Rodin G, Zimmermann C. Phase II study of an outpatient palliative care intervention in patients with metastatic cancer. J Clin Oncol. 2009 Jan 10;27(2):206-13. doi: 10.1200/JCO.2008.17.7568. Epub 2008 Dec 8. PMID 19064979
- BACKGROUNDJordhoy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol. 2001 Sep 15;19(18):3884-94. doi: 10.1200/JCO.2001.19.18.3884. PMID 11559726
- BACKGROUNDFerris FD, Bruera E, Cherny N, Cummings C, Currow D, Dudgeon D, Janjan N, Strasser F, von Gunten CF, Von Roenn JH. Palliative cancer care a decade later: accomplishments, the need, next steps -- from the American Society of Clinical Oncology. J Clin Oncol. 2009 Jun 20;27(18):3052-8. doi: 10.1200/JCO.2008.20.1558. Epub 2009 May 18. PMID 19451437
- BACKGROUNDAkechi T, Okuyama T, Akizuki N, Azuma H, Sagawa R, Furukawa TA, Uchitomi Y. Course of psychological distress and its predictors in advanced non-small cell lung cancer patients. Psychooncology. 2006 Jun;15(6):463-73. doi: 10.1002/pon.975. PMID 16173112
- DERIVEDAllende S, Turcott JG, Verastegui E, Rodriguez-Mayoral O, Flores-Estrada D, Perez Camargo DA, Ramos-Ramirez M, Martinez-Hernandez JN, Onate-Ocana LF, Pina PS, Cardona AF, Arrieta O. Early Incorporation to Palliative Care (EPC) in Patients With Advanced Non-Small Cell Lung Cancer: The PACO Randomized Clinical Trial. Oncologist. 2024 Oct 3;29(10):e1373-e1385. doi: 10.1093/oncolo/oyae050.