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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01631565
Acronym
PACO
Enrollment
201
Registered
2012-06-29
Start date
2012-05-31
Completion date
2016-01-31
Last updated
2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Palliative Care, Survival, Quality of life

Brief summary

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.

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.

Interventions

BEHAVIORALEarly allocation to palliative care

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

BEHAVIORALNutritional counseling

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

BEHAVIORALPsychoeducation.

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

Sponsors

Instituto Nacional de Cancerologia de Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Suicide Risk * Delirium * Cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Global survivalfrom inclusion until at least 6 months afterOverall 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

MeasureTime frameDescription
Progression Free Survivalfrom inclusion until at least 6 months afterIs 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 lifefrom inclusion until at least 6 months afterby EORTC QLQ C30, QLQ LC13

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026