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

This study has been completed.
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: November 23, 2016
Last verified: November 2016
  Purpose

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 Intervention Phase
Lung Neoplasms
Behavioral: Early allocation to palliative care
Behavioral: Nutritional counseling
Behavioral: Psychoeducation.
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.


Secondary Outcome Measures:
  • 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


Enrollment: 201
Study Start Date: May 2012
Study Completion Date: January 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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

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:
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: November 23, 2016
Health Authority: Mexico: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Yes

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 December 02, 2016