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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 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: May 30, 2013
Last verified: May 2013
  Purpose

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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 30, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2014