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Completed

NCT Number: NCT01631565

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

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.

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Institute- México

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Suicide Risk
  • Delirium
  • Cognitive impairment

Treatment and study plan

Early allocation to palliative care

Behavioral

Symptoms management (e.g. Pain, nausea, dehydration management).

Other names: experimental

Nutritional counseling

Behavioral

Nutritional status evaluation and dietary supplementation according to the patient requirements.

Psychoeducation.

Behavioral

Patient and care-taker psychoeducation, depression and anxiety evaluation.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

Management of Symptoms in Patients With Advanced Lung Cancer: Early Incorporation of Patient and Family to Attention and Care Program in Oncology

Acronym: PACO

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 29, 2012
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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