Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care (PACO)
|ClinicalTrials.gov Identifier: NCT01631565|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : November 25, 2016
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 or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Behavioral: Early allocation to palliative care Behavioral: Nutritional counseling Behavioral: Psychoeducation.||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Management of Symptoms in Patients With Advanced Lung Cancer: Early Incorporation of Patient and Family to Attention and Care Program in Oncology|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||January 2016|
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: experimentalBehavioral: Nutritional counseling
Nutritional status evaluation and dietary supplementation according to the patient requirements.Behavioral: Psychoeducation.
Patient and care-taker psychoeducation, depression and anxiety evaluation.
- 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.
- 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.
- Quality of life [ Time Frame: from inclusion until at least 6 months after ]by EORTC QLQ C30, QLQ LC13
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631565
|National Cancer Institute- México|
|Mexico City, Distrito Federal, Mexico, 0|
|Principal Investigator:||Oscar G Arrieta, MD Msc||Mexico. Nacional Cancer Institute|