Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care
NCT ID: NCT01631565
Last Updated: 2016-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2012-05-31
2016-01-31
Brief Summary
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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.
Detailed Description
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Patients with lung cancer have more symptoms than patients with other cancer. The impact on QoL and symptom management has acquired a great relevance. However, few studies demonstrating the benefit of early incorporation of palliative care in the management of patients with advanced lung cancer have been shown.
Palliative care is defined as the care given to patients with progressive active and advanced disease, and its main purpose is the relief and prevention of suffering and improving QoL.
In Mexico, the law defines palliative care as comprehensive care for those illnesses not responsive to curative treatment and include, but are not limited, to pain and other symptoms associated with the disease and psychological care, social and spiritual, of the patients and their families.
Psychological aspects The psychological manifestations in patients with lung cancer are determined by several factors. Depression and anxiety are the most common psychological reactions. It has been identified that 25% of cancer patients suffer from major depression at some point during the course of the disease and has been associated with decreased survival and QoL. Patients with anxiety disorders become more attached to medical treatment but seek alternative treatments more often. The main objective of psychological interventions is reducing maladaptive emotional reactions. In advanced stages, caregivers also confront stress and depression that could lead to health problems.
Nutritional aspects Malnutrition is reported in 60 to 79% in patients with lung cancer and is the largest contribution to morbidity and mortality. Cachexia is responsible directly or indirectly to death in one third of patients. The objectives of nutritional support are: improving tolerance to specific cancer treatment, decreasing the incidence of complications and, improving the QoL. Thus, it is necessary to conduct an early diagnosis of nutritional status in order to design nutritional intervention and improve their sense of comfort and QoL.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard care
Usual care given to the patients. Treatment, follow-up.
No interventions assigned to this group
Early Palliative Care
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.
Early allocation to palliative care
Symptoms management (e.g. Pain, nausea, dehydration management).
Nutritional counseling
Nutritional status evaluation and dietary supplementation according to the patient requirements.
Psychoeducation.
Patient and care-taker psychoeducation, depression and anxiety evaluation.
Interventions
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Early allocation to palliative care
Symptoms management (e.g. Pain, nausea, dehydration management).
Nutritional counseling
Nutritional status evaluation and dietary supplementation according to the patient requirements.
Psychoeducation.
Patient and care-taker psychoeducation, depression and anxiety evaluation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG 0-2
* Patients treated virgin
* Receive platinum-based chemotherapy
Exclusion Criteria
* Delirium
* Cognitive impairment
18 Years
90 Years
ALL
No
Sponsors
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Instituto Nacional de Cancerologia de Mexico
OTHER
Responsible Party
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Oscar Gerardo Arrieta Rodríguez MD
SNI II
Principal Investigators
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Oscar G Arrieta, MD Msc
Role: PRINCIPAL_INVESTIGATOR
Mexico. Nacional Cancer Institute
Locations
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National Cancer Institute- México
Mexico City, Mexico City, Mexico
Countries
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References
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Gore 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.
Nieder 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.
Follwell 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.
Jordhoy 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.
Ferris 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.
Akechi 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.
Allende 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.
Other Identifiers
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PACO2012
Identifier Type: -
Identifier Source: org_study_id