Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care (PACO)

• ClinicalTrials.gov Identifier: NCT01631565
• Recruitment Status: Completed
• First Posted: June 29, 2012
• Last Update Posted: November 25, 2016
• Sponsor: Instituto Nacional de Cancerologia de Mexico
• Information provided by (Responsible Party): Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Lung Neoplasms	Behavioral: Early allocation to palliative care; Behavioral: Nutritional counseling; Behavioral: Psychoeducation.	Phase 3

Detailed Description:

The multidisciplinary approach of palliative care for symptom management has an impact on the quality of life (QoL) of patients and their families. The World Health Organization (WHO) and the American Society of Clinical Oncology (ASCO) recommend incorporating early palliative care, simultaneously with cancer treatment. Unfortunately, this recommendation has not been followed in many cancer centers and late referrals to hospice are still frequent.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Management of Symptoms in Patients With Advanced Lung Cancer: Early Incorporation of Patient and Family to Attention and Care Program in Oncology
• Study Start Date: May 2012
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Standard care; Usual care given to the patients. Treatment, follow-up.
Experimental: 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.	Behavioral: Early allocation to palliative care; Symptoms management (e.g. Pain, nausea, dehydration management).; Other Name: experimental; Behavioral: Nutritional counseling; Nutritional status evaluation and dietary supplementation according to the patient requirements.; Behavioral: Psychoeducation.; Patient and care-taker psychoeducation, depression and anxiety evaluation.

Outcome Measures

Primary Outcome Measures :

1. Global survival [ Time Frame: from inclusion until at least 6 months after ]
   Overall survival will be determined from the date of commencement of treatment to date of death, regardless of the cause of death. In patients who did not die at the time of final analysis will use the date of last contact.

Secondary Outcome Measures :

1. Progression Free Survival [ Time Frame: from inclusion until at least 6 months after ]
   Is defined as the time from start of treatment until the date of the first documented evidence of progression (RECIST criteria) or the date of death for any reason in the absence of disease progression (EP). For patients who have died or progressed at the time of final analysis, use the date of last contact.
2. Quality of life [ Time Frame: from inclusion until at least 6 months after ]
   by EORTC QLQ C30, QLQ LC13

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Clinical stage IV
• ECOG 0-2
• Patients treated virgin
• Receive platinum-based chemotherapy

Exclusion Criteria:

• Suicide Risk
• Delirium
• Cognitive impairment

Contacts and Locations

Locations

Mexico

National Cancer Institute- México

Mexico City, Distrito Federal, Mexico, 0

Sponsors and Collaborators

Instituto Nacional de Cancerologia de Mexico

Investigators

• Principal Investigator: Oscar G Arrieta, MD Msc; Mexico. Nacional Cancer Institute

More Information

Publications:

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.

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.

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.

Jordhøy 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.

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.

• Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, SNI II, Instituto Nacional de Cancerologia de Mexico
• ClinicalTrials.gov Identifier: NCT01631565
• Other Study ID Numbers: PACO2012
• First Posted: June 29, 2012
• Last Update Posted: November 25, 2016
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:

Palliative Care; Survival; Quality of life

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases