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

This study is currently recruiting participants.
Verified June 2012 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01631565
First received: June 11, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

The multidisciplinary approach of palliative care for symptom management like psychological, emotional, spiritual, nutritional, among others, has an impact on the quality of life of patients and their families. Based on the foregoing, the World Health Organization (WHO) and the American Society of Clinical Oncology (ASCO) recommend incorporating early palliative care, simultaneously with cancer treatments. Unfortunately, this recommendation has not been incorporated in many cancer centers and late referrals to hospice are still frequent.

Lung cancer is the leading cause of cancer death worldwide, according to the literature, patients with lung cancer have more symptoms (arising from their disease, metastasis or comorbidities), than patients with other cancers. In this context, the impact on quality of life 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 quality of life.

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 Cancer is a disease that causes the greatest impact on the sufferer and the family, the impact occurs at different levels. The psychological manifestations in patients with lung cancer are determined by the clinical stage of disease, physical symptoms and treatments received, are depression and anxiety the most common psychological reactions. It has been identified that a quarter of cancer patients suffer from major depression at some point during the course of the disease. Depression has been associated with decreased survival and which strongly influences the evolution of lung cancer and quality of life. Patients with anxiety disorders become more attached to medical treatment but seek more alternative treatments far more often, and could interfere with treatment. Lung cancer is accompanied by a number of symptoms affecting negatively the quality of life of patients. The main objective of psychological interventions is reducing maladaptive emotional reactions.

Mainly in advanced stages, challenges are present for caregivers, including stress and depression, impacting on health problems and long term.

Nutritional aspects Malnutrition is reported in 60 to 79% in patients with lung cancer and is the largest contribution to morbidity and mortality. The highest expression of malnutrition in cancer is cachexia, which is responsible directly or indirectly to death in one third of patients. The objectives of nutritional support are improving tolerance to specific cancer treatment, decrease the incidence of complications and, above all, improve the quality of life. Thus it is necessary to conduct an early diagnosis of nutritional status. The terminal and palliative care diet plan must be designed to improve their sense of comfort and better quality of life.

Therefore patients included early in palliative care have better quality of life and survival.


Condition Intervention Phase
Lung Neoplasms
Behavioral: sham comparator
Behavioral: Early palliative care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • Global survival [ Time Frame: from inclusion until at least 6 months after ] [ Designated as safety issue: Yes ]
    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.

  • Progression Free Survival [ Time Frame: from inclusion until at least 6 months after ] [ Designated as safety issue: Yes ]
    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.

  • Quality of life [ Time Frame: from inclusion until at least 6 months after ] [ Designated as safety issue: Yes ]
    by EORTC QLQ C30, QLQ LC13


Estimated Enrollment: 124
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Standar care Behavioral: sham comparator
standard of care
Experimental: Palliative care
Early allocation to palliative care
Behavioral: Early palliative care
Early allocation to palliative care

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631565

Contacts
Contact: Oscar G Arrieta, MD M sc 56280400 ext 353 ogar@servidor.unam.mx

Locations
Mexico
National Cancer Institute- México Recruiting
Mexico City, Distrito Federal, Mexico, 0
Contact: Oscar G Arrieta, MD M sc     56 28 04 00 ext 353     ogar@servidor.unam.mx    
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Oscar G Arrieta, MD Msc Mexico. Nacional Cancer Institute
  More Information

No publications provided

Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, SNI II, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01631565     History of Changes
Other Study ID Numbers: PACO2012
Study First Received: June 11, 2012
Last Updated: June 27, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Palliative Care
Survival
Quality of life

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013