Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care
Lung Neoplasms
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Palliative Care, Survival, Quality of life
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Name: sham comparator Type: Behavioral
Name: Early palliative care Type: Behavioral
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Clinical stage IV

- ECOG 0-2

- Patients treated virgin

- Receive platinum-based chemotherapy

Exclusion Criteria:

- Suicide Risk

- Delirium

- Cognitive impairment
National Cancer Institute- México
Mexico City, Distrito Federal, Mexico
Status: Recruiting
Contact: Oscar G Arrieta, MD M sc - 56 28 04 00 - ogar@servidor.unam.mx
Start Date
May 2012
Completion Date
September 2013
Instituto Nacional de Cancerologia de Mexico
Instituto Nacional de Cancerologia de Mexico
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page